[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malaria-falciparum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malaria-falciparum":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,77,104,132,166,189,216,252,282,305],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100644507","phase-1-drug-interaction-assessment-of-gsk3772701-in-healthy-male-and-female-participants-aged-18-to-55-years-100644507",false,"NCT07670377","Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years","A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 55 Years to Investigate the CYP3A4 Interaction Potential of GSK3772701","Inclusion Criteria:\n\n1. Aged 18 to 55 years (inclusive), at the time of signing the informed consent form (ICF).\n2. Weight of at least 50 kg with a body-mass index \\\u003C=18.0 and \\\u003C=30.0 kg\u002Fm².\n3. Written informed consent obtained from the participant prior to performance of any study specific procedure, and which includes agreement to compliance, with the requirements and restrictions listed in the ICF and in this protocol.\n4. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of study assessments, return for follow-up visits).\n5. Participants who are healthy as established by medical evaluation including medical history, physical examination, cardiac monitoring, and clinical laboratory assessment before entering into the study.\n\n   Contraception:\n   * Male participants are eligible to participate.\n   * A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:\n6. Is a participant of non-childbearing potential (PONCBP). OR\n7. Is a POCBP and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1%, for 30 days prior to and during the study intervention period and for at least 7 days after the last dose of GSK3772701 and at least 2 days after the last dose of MDZ.\n8. A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening and within 24 hours before the first dose of study intervention.\n9. A blood sample for simultaneous follicle-stimulating hormone (FSH) may be collected, and estradiol levels may be included at investigator's discretion to confirm non-reproductive potential when menopausal status is uncertain according to the local laboratory reference range.\n\nExclusion Criteria:\n\n1. History or presence\u002Fsignificant history of or current cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, immunological, dermatological, endocrine, hematologic, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n2. Any condition where the administration of MDZ could be contraindicated, including but not limited to, hypersensitivity (MDZ, any of its excipients, or to any benzodiazepines), sleep apnea, glaucoma (narrow-angle glaucoma, acute or open angle glaucoma, untreated), myasthenia gravis, respiratory insufficiency, impaired pulmonary function, or severe hepatic impairment.\n3. History of any malignancy within the past 5 years. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which is considered cured with minimal risk of recurrence. Participants under evaluation for possible malignancy are not eligible.\n4. History of any reaction or hypersensitivity likely to be exacerbated by any component (formulation, capsule, or excipients) of the study intervention(s) (including hypromellose \\[hydroxypropyl methylcellulose\\] for GSK3772701) or allergies to cherries (as per MDZ USPI).\n5. Acute or chronic clinically significant pulmonary, endocrinological, cardiovascular, muscular, neurological, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n6. Participants should have baseline clinical laboratory values (renal, hepatic, and hematological) within normal limits or clinically acceptable to the investigator. A participant with a clinical abnormality or laboratory parameter(s) which is\u002Fare not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the investigator considers that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.\n7. Participants with supine blood pressure (BP) \\>=140 mm Hg (systolic) or \\>=90 mm Hg (diastolic).\n8. Estimated glomerular filtration rate (eGFR) of \\\u003C80 mL\u002Fmin\u002F1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021).\n9. The participant must agree to and adhere to the concomitant therapy (including non-drug therapies) restrictions from the Screening Visit through to the end of the study.\n10. Any other clinical condition that, in the opinion of the investigator, might pose an additional risk to the participant due to participation in the study or would make adhering to study procedures for the duration of the study difficult.\n11. Sensitivity to heparin or heparin-induced thrombocytopenia.\n12. Past or intended use of over-the-counter or prescription medication (including herbal medications, vitamins and supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer), or 5 times the half-life (whichever is longer) prior to dosing.\n13. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) or investigational drugs or non-registered product (drug, vaccine, or medical device) within 3 months or 5 times the half-life (whichever is longer) prior to dosing.\n14. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n15. Current or prior enrolment in this or any other clinical study involving an investigational study intervention, or any other type of medical research, within the last 30 days or 5 half-lives, whichever is longer, prior to signing of the ICF.\n\n    Participants who screen fail for the current study are not eligible for re-screening or enrollment.\n16. Positive drug\u002Falcohol screen, including tetrahydrocannabinol at Screening or Admission.\n17. Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months prior to Screening.\n18. Positive human immunodeficiency virus (HIV) antibody test.\n19. Regular alcohol consumption within 6 months prior to the clinical study defined as: An average weekly alcohol intake of 14 units for males or 7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint. (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.\n20. Regular use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to \"vape\".\n21. Participants who have lost or donated over 500 mL of blood within 90 days prior to enrollment or intend to donate blood or blood products during the study.\n22. Participants who have donated plasma within 7 days prior to enrollment.\n23. Any study personnel or their immediate dependents, family, or household members.\n24. Regular use of known drugs of abuse, including tetrahydrocannabinol.\n25. The following liver safety criteria are exclusionary:\n\n    * Alanine aminotransferase (ALT) \\>1.5 × the upper limit of normal (ULN).\n    * Total bilirubin \\>1.5 × ULN. Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5 × ULN if direct bilirubin is \\\u003C=1.5 × ULN.\n    * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n    * Presence of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at Screening or within 3 months prior to first dose of study intervention.\n    * Positive hepatitis C antibody test results at Screening or within 3 months prior to first dose of study intervention.\n    * Positive hepatitis C RNA test results at Screening or within 3 months prior to first dose of study intervention.\n26. QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 msec.\n27. The participant has congenital long QT syndrome or known prolongation of the QTc interval.\n28. The participant has a family history of QT prolongation or sudden death.\n29. The participant has any current or previous history of episodes of symptomatic bradycardia or bradyarrhythmia.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study aims to evaluate whether GSK3772701 alters the pharmacokinetics (PK) of midazolam (MDZ), a standard probe substrate for the CYP3A4 enzyme. The findings are planned to be used to determine whether GSK3772701 acts as an inducer and\u002For inhibitor of CYP3A4 and will help guide recommendations for safe co-administration with CYP3A4 substrates.",[28],"Malaria, Falciparum",[30,31,32,33,34,35],"GSK3772701","Pharmacokinetics","Midazolam","CYP3A4","Healthy participants","Open label","NOT_YET_RECRUITING","2026-06-19",{"date":39,"type":40},"2026-06-26","ACTUAL",{"date":39,"type":22},{"date":43,"type":22},"2026-08-31",{"name":45,"class":46},"GlaxoSmithKline","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100582372","phase-1-safety-tolerability-and-efficacy-of-pfspz-larc2-vaccine-against-chmi-in-malaria-nave-adults-100582372","NCT06862453","Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults","Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults","LARC-Tu","Inclusion Criteria:\n\n* Healthy adults (male or non-pregnant female) 18 to 45 years of age.\n* Able and willing to participate for the duration of the study.\n* Able and willing to provide written informed consent.\n* Physical examination and laboratory results without clinically significant findings.\n* Women of childbearing potential must agree to use effective means of birth control (e.g. oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) during the entire study.\n* Due to the potential for reduced effectiveness of hormonal contraceptives during artemether and\u002For lumefantrine treatment, participants will be counseled to add an additional barrier method of contraception during treatment.\n* Women with a history of surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider.\n* Agree not to travel to a malaria endemic region during the course of the trial.\n\nExclusion Criteria:\n\n* Unable to provide informed consent including inability to pass the test of understanding.\n* Receipt of a malaria vaccine in a prior clinical trial.\n* History of a splenectomy or sickle cell disease.\n* History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.\n* Current use of systemic immunosuppressant pharmacotherapy.\n* Receipt of a live vaccine within 4 weeks of first immunization or of 3 or more non-live vaccines within 2 weeks of first immunization.\n* Women who are breast-feeding, pregnant or planning to become pregnant during the study period.\n* Known allergy or hypersensitivity reaction (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone-proguanil (Malarone®), artemether-lumefantrine (Coartem®), any components of these formulations, or any component of the investigational products.\n* History of anaphylaxis or other life-threatening reaction to a vaccine.\n* Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected.\n* Evidence of increased cardiovascular disease risk; defined as \\>10% five-year risk by non-laboratory method (Gaziano, 2008) \\[80\\].\n* Plan to participate in another investigational vaccine\u002Fdrug research during the study.\n* Plan for major surgery between enrollment until 28 days post-CHMI.\n* Use or planned use of any drug with anti-malarial activity that would precede or coincide with malaria challenge or vaccination.\n* Anticipated use of medications known to cause drug reactions with atovaquone-proguanil or artemether-lumefantrine such as tetracycline, rifampin, rifabutin, cimetidine, metoclopramide, antacids, anti-coagulants such as coumarin, indinavir, and kaolin.\n* Anticipated use of medications known to:\n\n  * Be substrates, inhibitors or strong inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin, and\u002For St. John's wort) \\[strong inducers of CYP3A4 when taken concomitantly with artemether and\u002For lumefantrine can result in decreased concentration(s) and loss of antimalarial efficacy\\].\n  * Be metabolized by the cytochrome enzyme CYP2D6 (e.g., primaquine, tafenoquine, flecainide, imipramine, amitriptyline, clomipramine).\n  * Have a mixed effect on CYP3A4 (e.g., antiretrovirals).\n  * Prolong the QT interval (e.g., quinine, quinidine, halofantrine, mefloquine, procainamide, disopyramideamiodarone, sotalol, pimozide, ziprasidone, tetracycline, doxycline, fluoroquinolone, imidazole, and triazole antifungal agents). Note: in the case of halofantrine, this drug may not be used within a month of artemether\u002Flumefantrine due to its very significant effect on QT interval.\n* Positive HIV, HBsAg or HCV serology.\n* An abnormal electrocardiogram, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram.\n* History of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.\n* Family history (grandparents, parents or siblings) of congenital prolongation of the QT interval or sudden death.\n* History of disturbances of the electrolyte balance (e.g., hypokalemia or hypomagnesemia).\n* History of severe renal impairment (creatinine clearance \\\u003C30 mL\u002Fmin) (risk of pancytopenia in patients with severe renal impairment treated with proguanil).\n* History of chronic liver disease.\n* Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving.\n* Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study. This includes persons in emergency situations such as refugees.","45 Years",{"count":57,"type":22},58,[25],"This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria infection (CHMI). PfSPZ-LARC2 Vaccine contains a deletion of two genes, the Mei2 and LINUP genes, and undergoes developmental arrest in the late liver stages without releasing merozoites into the blood stream (blood stage parasites).\n\nThe primary objective of the study is to assess the safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population.",[61],"Malaria Falciparum",[63,64,65],"malaria","Plasmodium falciparum","PfSPZ-LARC2 Vaccine","RECRUITING","2026-06-17",{"date":69,"type":40},"2026-06-22",{"date":71,"type":40},"2026-03-12",{"date":73,"type":22},"2026-12-30",{"name":75,"class":46},"Sanaria Inc.",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":76},"100593828","phase-1-single-ascending-dose-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-lai-mmv055-alone-and-in-combination-with-mmv371-in-healthy-participants-100593828","NCT07011511","Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants","A First-in-Human, Single-Centre, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Intramuscular Injection(s) of Long-Acting Injectable Formulations of MMV055 Alone (Part A) and in Combination With MMV371 (Part B) in Healthy Participants","Inclusion Criteria:\n\n1. Must provide written informed consent\n2. Must be willing and able to communicate and participate in the whole study\n3. Aged 18 to 60 years inclusive at the time of signing informed consent\n4. Must agree to adhere to the contraception requirements defined in the study protocol\n5. Healthy male or healthy WONCBP (Parts A and B), or healthy non-pregnant, non-lactating female participants (Part B only) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities. Safety bloods, urinalysis, ECGs and vital signs to be re-checked at admission and\u002For pre-dose\n6. Body mass index (BMI) of 19.0 to 30.0 kg\u002Fm2 as measured at screening\n7. Weight ≥50 kg for males and ≥45 kg for females at screening\n\nExclusion Criteria:\n\n1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients (Parts A and B), Wellvone®\u002FMepron® and\u002For Malarone® (Part B only)\n2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active\n3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator\n4. Family history of sudden death, or family history of clinically significant cardiovascular disease, as judged by the investigator\n5. Systolic BP \\>140 or \\\u003C90 mmHg, diastolic BP \\>90 or \\\u003C50 mmHg, or heart rate (HR) (based on vital signs assessment) \\>100 or \\\u003C45 bpm, confirmed by repeat assessment at screening\n6. Any finding in the medical examination (including BP, HR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n7. History or presence of known structural cardiac abnormalities, family history of long QT syndrome, cardiac syncope or recurrent, idiopathic syncope, exercise related clinically significant cardiac events. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QT changes\n8. Presence of sinus node dysfunction, clinically significant PR interval prolongation (\\>220 msec), intermittent second- or third-degree atrioventricular block, complete bundle branch block, sustained cardiac arrhythmias including (but not limited to) atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with the exception of isolated extra systoles, abnormal T wave morphology which may impact on the QT\u002FQTc assessment, or QTcF \\>450 msec based on the mean of the triplicate values and confirmed by single repeat assessment at screening\n9. Participants with a history of cholecystectomy or gall stones\n10. Participants who do not have suitable veins for multiple venepunctures\u002Fcannulation as assessed by the investigator or delegate at screening\n11. Participants with tattoos or scars or other significant dermatological conditions overlying the deltoid or gluteal region which may interfere with injection site assessments, as determined by the investigator or delegate at screening\n12. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in the study protocol). Participants with Gilbert's Syndrome are not allowed\n13. Dyslipidaemia (cholesterol and\u002For triglycerides) requiring pharmacological intervention or fasting triglycerides \\>2.26 mmol\u002FL, fasting cholesterol \\>6.20 mmol\u002FL, low density lipoprotein cholesterol \\>3.75 mmol\u002FL)\n14. Fasting blood glucose ≥6.1 mmol\u002FL\n15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results\n16. Transaminases (ALT or AST) \\>ULN\n17. Females who are pregnant or lactating (all female participants must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission)\n18. Part A only: females of childbearing potential. A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is post-menopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone \\[FSH\\] concentration ≥40 IU\u002FL).\n19. Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer\n20. Participants who have previously been administered MMV055 in this study\n21. Participants who report to have previously received MMV371\n22. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood\n23. Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day, up to 800 mg ibuprofen per day, hormonal contraception or HRT) in the 14 days before IMP administration (see study protocol). Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial participant; and if the use of medication is not considered to interfere with the objectives of the study.\n24. Participants who are taking, or who have taken, rifampin\u002Frifabutin, tetracycline and indinavir in the 30 days before IMP administration (Part B only)\n25. Live vaccines within 30 days of IMP administration, or plans to receive such vaccines during the study\n26. Participants who have had a COVID 19 vaccine within 14 days before dosing\n27. History of any drug or alcohol abuse in the past 2 years\n28. Regular alcohol consumption in males \\>21 units per week and in females \\>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)\n29. A confirmed positive alcohol breath test at screening or admission\n30. Current smokers and those who have smoked within the last 12 months\n31. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months\n32. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission\n33. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in the study protocol) at screening or admission\n34. Male participants with pregnant or lactating partners\n35. A score of SI 4 to 5 (related to suicidal ideation) or any SB score (related to suicidal behaviour) as assessed using the Columbia-Suicide Severity Rating Scale (C SSRS)\n36. Participants who are, or are immediate family members of, a study site or sponsor employee\n37. Failure to satisfy the investigator of fitness to participate for any other reason","60 Years",{"count":86,"type":22},72,[25],"This is a single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of MMV055 administered alone (Part A) and in combination with MMV371 (Part B) in healthy participants.\n\nIt is planned to enroll up to 6 sequential cohorts of 8 healthy male participants and healthy female participants of non-childbearing potential in Part A. In Part B, up to 3 sequential cohorts of 8 healthy male participants and healthy non-pregnant, non-lactating female participants will be enrolled. In each cohort, participants will be randomised in a ratio of 6 active investigational medicinal product (IMP) to 2 placebo.\n\nPart A of the study will include two components, Parts A1 and A2. Part A1 includes two initial cohorts, with planned doses of 40 and 100mg, respectively. It is intended to document the human elimination T1\u002F2 of MMV055, which will then be used to shorten the proposed End of Study (EOS) of 48 weeks, if possible.\n\nAll cohorts will follow a sentinel dosing design. On Day 1, two sentinel participants (sentinel group) will be randomly assigned to receive a single IM dose of either active IMP or placebo (1 participant each) to assess safety and tolerability (including ISRs).\n\nThe sentinel group will be dosed concomitantly at least 7 days prior to the rest of the cohort (main group). The main group will comprise 6 participants randomly assigned to receive a single IM dose of either active IMP or placebo in a 5:1 ratio to assess safety and tolerability (including ISRs).",[28],[91,92,93],"Malaria","First In Human","Healthy Volunteers","2026-06-12",{"date":96,"type":40},"2026-06-15",{"date":98,"type":40},"2025-06-30",{"date":100,"type":22},"2027-12-02",{"name":102,"class":103},"Medicines for Malaria Venture","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100642860","phase-1-first-in-human-dose-escalation-of-gsk4425689a-safety-tolerability-and-pk-in-healthy-adults-100642860","NCT07646353","First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults","A First-in-Human Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK4425689A in Healthy Adult Participants","Inclusion Criteria:\n\n1. Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.\n2. Participants must have a body weight between 50 and 100 kg, inclusive and body-mass index (BMI) within the range of 18.0 to 32.0 kg\u002Fm\\^2.\n3. Participants must be healthy male or female participant of non-childbearing potential (PONCBP).\n4. Participants must be capable of giving signed informed consent prior to any study-specific procedures, which include compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n5. Participants must demonstrate the ability to understand and comply with the study requirements, including attendance for all scheduled visits and adherence to protocol-specified procedures and restrictions. Participants must be willing to remain in close contact with study personnel and reliably record data as instructed.\n6. Participants must be in good general health and have no significant ongoing medical conditions, as determined by comprehensive medical history, thorough physical examination, vital signs assessment, 12-lead ECG, and clinical laboratory evaluations (including hematology, biochemistry, and urinalysis).\n7. Participants should have baseline (screening) clinical laboratory values (renal, hepatic, and hematological) within normal limits or clinically acceptable to the investigator. A participant with a clinical abnormality or laboratory parameter(s) which is\u002Fare not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the investigator considers that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.\n8. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin levels must be within the normal range at Screening.\n\nExclusion Criteria:\n\n1. Participants with a history of malaria infection or who have previously participated in malaria vaccine trials or studies involving experimental anti-malarial monoclonals, small molecule drugs, or experimental malaria challenge are excluded. Participants who have been vaccinated against malaria with an investigational or approved vaccine (e.g., RTS,S and R21\u002FMatrix-M) are excluded.\n2. History of allergy to humanized monoclonal antibodies (mAbs) or constituents of the formulation.\n3. Any history of anaphylaxis or other severe allergic reactions, or food, or drug allergy that may impact participant safety in the opinion of the investigator.\n4. Recent history of, or presence of a current or suspected chronic disease that may impact participant safety, or impact interpretation of clinical study results. This includes illnesses such as (but not limited to) cardiac disease, autoimmune disease, diabetes, progressive neurological disease, severe malnutrition, hepatic or renal disease, epilepsy, chronic obstructive pulmonary disease or asthma (except resolved childhood asthma, which is acceptable). Conditions that in the opinion of the investigator constitute a risk to the individual when taking the study intervention or likely to interfere with the interpretation of data.\n5. Have a history of malignant neoplasm (other than localized basal or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of Screening, regardless of whether there is evidence of local recurrence or metastases.\n6. Current enrolment or participation in another clinical study.\n7. Participation in another clinical study involving any investigational product within the past 90 days or within a period equivalent to 5 half-lives of the investigational drug, whichever is longer, or receipt of experimental non-malaria vaccines or mAbs within the past 12 months prior to signing the informed consent.\n8. QT corrected for heart rate by Fridericia's formula (QTcF) \\>450 msec.\n9. Presence or history of cardiac arrhythmias or cardiac disease or a family or personal history of long-QT syndrome.\n10. Average heart rate of \\\u003C40 or \\>100 beats per minute (bpm).\n11. Evidence of previous myocardial infarction or any clinically significant conduction abnormality such as left bundle branch block, atrioventricular (AV) block (2nd degree or higher), Wolff-Parkinson-White syndrome, atrial fibrillation, and atrial flutter. A long-standing right bundle branch block is permitted.\n12. Participants cannot take investigational product with biologic agents (such as mAbs including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to signing the informed consent.\n13. Past or intended use of over the counter or prescription medication, including herbal medications or cannabidiol (CBD)-based products within 14 days prior to administration of study intervention.\n14. Recent infection or illness:\n\n    * Participants with any acute illness or infection requiring treatment within 28 days prior to Screening are excluded (but may be re-screened if appropriate).\n    * Participants with evidence of active infections, such as Coronavirus disease 2019 (COVID-19) or tuberculosis are excluded.\n15. Participants who have received any live vaccines within 3 months prior to Screening or plan to receive such vaccines during the clinical study.\n16. Positive drug screen at Screening, including tetrahydrocannabinol, indicating use of known recreational drugs or drugs of abuse.\n17. An average weekly alcohol intake of \\>21 units per week for male participants and \\>14 units per week for female participants within 6 months prior to Screening. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.\n18. Any individual who is a current smoker or has a history of cigarette smoking of more than 5 pack years or regular use of tobacco- or nicotine-containing products within 6 months prior to Screening (including e-cigarettes or vaping).\n19. Pregnancy and lactation:\n\n    * Participants of childbearing potential (POCBP) are excluded.\n    * Pregnant or breastfeeding females are excluded.\n20. Participants who have donated 500 mL or more of blood or blood products within 12 weeks before administration of study intervention are excluded.\n21. Concomitant conditions:\n\n    * Positive human immunodeficiency virus (HIV) antibody test.\n22. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for clinically established Gilbert's syndrome or asymptomatic gallstones).\n23. Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to first dose of study intervention.\n24. Positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention.\n25. Positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention.\n26. History of severe reactions to IV or SC injections (e.g., anaphylaxis, vasovagal syncope).","65 Years",{"count":113,"type":22},40,[25],"This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.",[28],[91,118,119,120,121,122,123,124,125],"GSK4425689A","First-in-human","Safety","Tolerability","Pharmacokinetic","Healthy Adults","Dose escalation","Monoclonal antibody (mAb)","2026-06-09",{"date":94,"type":40},{"date":94,"type":22},{"date":130,"type":22},"2028-04-19",{"name":45,"class":46},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":16,"sex":17,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":151,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":76},"100635079","phase-1-safety-and-pk-of-mmv371-lai-in-healthy-adults-and-adolescents-in-rwanda-100635079","NCT07548021","Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda","A Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 Long-Acting Injection in Healthy Adults and Adolescents in Rwanda","Inclusion Criteria:\n\n1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents, written assent and parental\u002Flegal authorized representative (LAR) consent must be obtained, in accordance with local regulations.\n2. Able to provide proof of identity to the satisfaction of the Investigator or delegate completing the enrolment process\n3. Able and willing to communicate effectively and comply with all study procedures for the duration of the study (including IM injections, safety assessments, blood sampling, malaria monitoring, follow-up visits)\n4. Living within local jurisdiction of trial site(s) and available for the duration of the trial Demographics and Contraception\n5. Male or female participants aged 12 to 50 years inclusive at the time of signing informed consent\u002Fassent.\n6. WOCBP must be non-pregnant and non-lactating, confirmed by a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission, prior to IMP administration. WOCBP must agree to use, at minimum, acceptable contraception methods, as defined by the Clinical Trials Coordination Group (CTCG) guidance, from 21 days prior to study Day 1 through the End-of Study visit (Week 24) (Clinical Trials Coordination Group (CTCG), 2024).\n7. Post-menopausal participants must have menopause confirmed at screening, defined as a follicle-stimulating hormone (FSH) level ≥ 25.8 mIU\u002FmL Baseline Characteristics\n8. Healthy volunteers, as determined by:\n\n   physical examination Vital signs 12 lead ECG absence of malaria symptoms at baseline (note: a positive blood smear without malaria symptoms at baseline is not exclusionary) Hematology, biochemistry or urinalysis results at screening or at the admission visit (Day -1) that are within the standard clinically acceptable laboratory ranges defined for this study (See section 10.7 Appendix 7)\n9. For adults (18-50 years): Body Weight ≥45 kg at screening\n10. For adolescents (12-17 years): body weight ≥35 kg at screening Participant-reported outcomes (PROs)\n11. Able to understand and complete participant-reported outcome assessments (e.g., injection-site reaction diary and injection acceptability assessments), either independently or with assistance, in a language and format approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  1. Positive malaria blood smear microscopy at the Admission visit (Day -1).\n  2. Acute febrile illness within 96 hours prior to enrolment or within 96h prior to Day 1.\n  3. Serious adverse reaction or clinically significant hypersensitivity to drugs or formulation excipients used in the study: artemether-lumefantrine (Coartem® or generic formulations) and atovaquone (Wellvone®\u002FMepron® and\u002For Malarone® or their generics).\n  4. Any history of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis prior to enrolment that, in the opinion of the Investigator, has a reasonable risk of recurrence during the trial.\n  5. Any current uncontrolled medical or psychiatric condition, or substance abuse problems that, in the opinion of the Investigator, would make it unlikely for the participant to comply with the protocol, may interfere with study assessments, or could jeopardize the safety of the participant.\n  6. Evidence of clinically significant neurologic, cardiac, gastro-intestinal, dermatologic, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, haematological, oncologic, or renal disease, as determined by medical history, physical examination, and\u002For laboratory evaluations, including urinalysis.\n  7. History of a bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or a history of significant bruising with blood draws.\n  8. Known or documented sickle cell disease by history. Note: known sickle cell trait is not exclusionary.\n  9. Presence of sinus node dysfunction; clinically significant PR interval prolongation (\\>220 msec); intermittent second- or third-degree atrioventricular block; complete bundle branch block; sustained cardiac arrhythmias including, but not limited to, atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia except isolated extrasystoles; abnormal T wave morphology that may interfere with QT\u002FQTc assessment; or QTcF \\>450 msec (adults and adolescents).\n\n     Physical Examination\n  10. Participants who do not have adequate venous access for multiple venipunctures or cannulation, as assessed by the Investigator or delegate at screening.\n  11. Participants with tattoos, scars or other clinically significant dermatological lesions or conditions overlying the deltoid, gluteal, or vastus lateralis region that, in the opinion of the Investigator, may interfere with injection site assessments.\n\n      Diagnostic Assessments\n  12. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab). or human immunodeficiency virus (HIV) 1 and 2 antibody results.\n\n      Prior Study Participation\n  13. Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or within fewer than 5 elimination half-lives prior to Day 1 (whichever is longer). Note: Past, current, or planned participation in non-interventional (observational) studies is not exclusionary.\n  14. Participants who are currently enrolled in another interventional clinical trial within 90 days prior to Day 1, or who intend to participate in another interventional clinical trial during their participation in this study.\n  15. Donation of blood or plasma, or loss of more than 400 mL of blood, within 90 days prior to Day 1.\n\n      Prior and Concomitant Medication or Vaccine\n  16. Use of antimalarial chemoprevention or treatment, and\u002For antibiotics with known antimalarial activity (see Section 10.6 Appendix 6), within 6 weeks or fewer than 5 elimination half-lives prior to Screening (whichever is longer).\n  17. Current or recent (within 30 days prior to Day 1) use of rifampin\u002Frifampicin, rifabutin, tetracycline, or indinavir due to potential drug-drug interaction risk with atovaquone.\n  18. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \\>10 mg\u002Fday) or other immunosuppressive drugs within 30 days prior to Day 1.\n  19. Receipt of a live attenuated vaccine within 4 weeks or an inactivated vaccine within 2 weeks prior to Day 1.\n  20. Receipt or planned receipt during the study of any doses of a malaria vaccine (investigational or registered, such as RTS, S\u002FAS01 or R21\u002FMatrix-M) or monoclonal antibodies (mAb) directed against Plasmodium falciparum.\n  21. Receipt of immunoglobulins and\u002For blood products within the past 6 months. Lifestyle Characteristics\n  22. History or medical, occupational, or family problems related to alcohol or illicit drug use within the past 12 months that, in the opinion of the Investigator, may interfere with study participation, compliance, or participant safety.\n\n      Other Exclusion Criteria\n  23. Participants who are, or are immediate family members of, study site staff or Sponsor employees involved in the conduct of the study.\n  24. Any other condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study or could compromise participant safety or data integrity.","12 Years","50 Years",{"count":142,"type":22},80,[25],"This Phase 1b study will assess the safety, tolerability and pharmacokinetics (PK, this measures the levels of study drug in the body) of a single injection of MMV371 in healthy adult and adolescent participants in Rwanda. MMV371 has been designed as a long acting injection (LAI). Protective efficacy (PE) will be assessed as an exploratory endpoint. Protective efficacy measures if participants are protected from becoming ill with malaria whilst the MMV371 is still present in their body. The study will enroll approximately 80 healthy male and female participants, aged 12 to 50 years. Before starting the study participants will be given a standard approved course of artemether lumifantrine (AL) to clear any malaria infection they have. Once the AL course has been completed the study drug will be given by injection in the muscle of the upper arm, the side of the thigh, or the hip. Three out of four participants will receive MMV371 and 1 in four participants will receive placebo. Placebo is a dummy medicine. All participants have an equal chance of being assigned to receive the injection in the upper arm, outer thigh or hip. Neither the participants nor the researchers treating the participants will know who received MMV371 or placebo until after the study is completed.\n\nKey study features include:\n\n* Study duration for each participant: up to 7 months\n* MMV371 or placebo given: a single intramuscular (IM) injection\n* Visit schedule: Participants will remain in-clinic on Days -1-2 (2 overnight stays), followed by 15 follow-up visits: Day 4, then weekly for 1 month, and subsequently every 2 weeks until the End-of-Study (EoS) visit at Week 24.\n\nThese frequent visits are necessary to monitor safety, the levels of MMV371 in the body, and to perform malaria detection testing until EoS (Week 24).",[146,61,147,148,149,91,150],"Malaria (Plasmodium Falciparum)","Malaria Infection","Malaria Prophylaxis","Malaria Prevention","Malaria Parasitaemia",[152,153,154,155,156,157],"malaria prevention","malaria prophylaxis","malaria falciparum","Malaria infection","Malaria Long-Acting Injectable","Long-Acting Injectable","2026-04-17",{"date":160,"type":40},"2026-04-23",{"date":162,"type":22},"2026-09",{"date":164,"type":22},"2028-03",{"name":102,"class":103},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":111,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100634899","phase-2-a-phase-2a-study-of-a-novel-antimalarial-pyrrolidinamide-in-adult-patients-with-uncomplicated-p-falciparum-malaria-100634899","NCT07545681","A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria","A Phase 2A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel Antimalarial Pyrrolidinamide at Different Doses and Dose Durations, in Adult Patients With Uncomplicated P. Falciparum Malaria","Inclusion Criteria:\n\n* Male and female patients aged 18 to 65 years.\n* Presence of malaria due to mono-infection with P. falciparum confirmed by:\n\n  * Fever, as defined by axillary temperature \\>=37.5°C or oral\u002Ftympanic temperature \\>=38°C and,\n  * Microscopically confirmed P. falciparum malaria parasite mono-infection,\n  * A parasite count between 2,000 to 60,000 asexual parasite count\u002FµL of blood for P. falciparum.\n* Have a BMI between \\>=18 and \\\u003C=30 kg\u002Fm2.\n* Able to swallow oral medication.\n* Signed informed consent, acknowledging understanding and willingness to comply with the requirements of the study. If the patient is unable to write, thumb print consent, signed by an impartial witness is permitted according to local ethical considerations.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n  * Is a woman of non-childbearing potential (WONCBP) or\n  * Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method, from Study Day 1, and during the study intervention period (40 +\u002F-3 days).\n\nExclusion Criteria:\n\n* Patients with signs and symptoms of severe\u002Fcomplicated malaria according to the WHO 2024 Criteria.\n* Mixed Plasmodium infection, i.e., infection with more than one malaria (plasmodium) species (by microscopy; participant to be withdrawn from study treatment if PCR subsequently indicates presence of mixed infection).\n* Abnormal values: QTcF \\>450 msec or QTcF \\>480 msec for patients with bundle branch block.\n* Any clinically significant ECG abnormalities at Screening unrelated to malaria (including but not limited to, second degree AV block (Mobitz Type 2), complete heart block, ST changes, atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, prolonged QT interval.\n* History of malignancy (or current malignancy) of any organ system (other than localized carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n* Creatinine \\>=2 x ULN.\n* Significant illness within two weeks prior to screening.\n* Positive HIV antibody test at screening, or history of HIV infection based on past positive test result, clinical record or current treatment.\n* Severe vomiting, defined as more than 3 times in the 24 hours before screening or inability to tolerate oral treatment.\n* Severe diarrhoea defined as more than 3 watery stools per day in the 24 hours before screening.\n* Known history or evidence (based on clinical examination or investigation) of uncontrolled active cardiovascular disease (including hypertension), respiratory disease (including active tuberculosis even if treatment is ongoing), liver cirrhosis or liver disease (based on prior investigation, clinical signs and\u002For interpretation of liver enzymes), other active hepatic, renal, gastrointestinal, immunological, neurological, endocrine, infectious, or psychiatric disease.\n* Anaemia (Hb \\\u003C=8.0g\u002Fdl) or known clinically important chronic underlying haematological disease such as sickle cell disease at screening.\n* Significant chronic medical conditions which in the opinion of the investigator preclude enrolment into the study.\n* Have received any antimalarial treatment in the preceding 6 weeks (see Section 6.10), as determined by history or medical record.\n* Prior enrolment in this study and receipt of treatment with GSK3772701.\n* Use of other investigational drugs at the time of enrolment, or within 6 weeks, or 5 half-lives prior to enrolment into this study, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.\n* History of hypersensitivity to the study drug or drug formulation and capsule (Hypromellose (hydroxypropyl methylcellulose)) constituents.\n* History of drug or alcohol abuse within 3 months prior to dosing, or clinical evidence of such abuse.\n* Participants who in the opinion of the Investigator are unsuitable for participation in the study or cannot be enrolled due to logistical reasons.\n* ALT \\>2.0 x ULN.\n* Total bilirubin \\>1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5xULN as long as direct bilirubin is \\\u003C=1.5xULN.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n* Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.\n\nNote: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.\n\n• Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.\n\nNote: Test is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.",{"count":174,"type":22},70,[176],"PHASE2","The study will evaluate the safety and efficacy of a new antimalarial drug GSK3772701 (a pyrrolidinamide), using different doses and treatment durations, in adult participants with uncomplicated Plasmodium (P.) falciparum malaria.",[28],[30,180,64,91],"Antimalarial drug","2026-04-16",{"date":183,"type":40},"2026-04-22",{"date":185,"type":22},"2026-04-20",{"date":187,"type":22},"2027-07-22",{"name":45,"class":46},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":76},"100529233","phase-1-a-study-to-investigate-the-safety-of-gsk4024484-in-healthy-adult-participants-100529233","NCT06171113","A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants","A Phase 1, Randomised, Double Blind Placebo-controlled, First Time in Human Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Oral Doses and Food Effect of GSK4024484 in Healthy Adult Participants.","Inclusion Criteria:\n\n1. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.\n2. Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment.\n3. A participant with a clinical abnormality or laboratory parameter(s) which is\u002Fare not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the Investigator considers, that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.\n4. ALT (Alanine transaminase) and AST (Aspartate transaminase) within the normal range at screening.\n5. Total bilirubin within the normal range unless the participant is known to have Gilbert's syndrome.\n6. Body weight ≥50kg, and BMI within the range 19 to 32 kilogram per square metre (kg\u002Fm\\^2) inclusive.\n7. Male participants and female participants who are not of child bearing potential.\n8. The participant is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.\n\nExclusion Criteria:\n\n1. History or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data in the opinion of the investigator.\n2. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n3. An average weekly alcohol intake of \\>14 units a week within 6 months prior to the study. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.\n4. QTcF (Fridericia's formula) \\>450 msec based on average of triplicate ECGs. The QTcF is the QT interval corrected for heart rate according to QTcF.\n5. More than 100 ventricular ectopic complexes in 24 hrs by Holter screening or any other clinically significant Holter abnormalities determined by the investigator.\n6. Presence or history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.\n7. Heart rate \\\u003C40 or \\>100 beats per minute (bpm).\n8. Evidence of previous myocardial infarction or any clinically significant conduction abnormality such as (including but not specific to left complete bundle branch block, AV block \\[2nd degree or higher\\], WPW syndrome). Long standing RBBB is permitted.\n9. Past or intended use of over-the-counter or prescription medication, including herbal medications, CBD-based products, PPIs or H2 antagonists within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longest) prior to dosing. Other concomitant medication may be considered on a case by case basis by the investigator in consultation with the medical monitor. Paracetamol is permitted (capped at ≤2 grams\u002Fday).\n10. Participation in the study that would result in loss of blood or blood products in excess of 500 mL within a 56-day period.\n11. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n12. Current enrolment or past participation (within the last 30 days before planned first dose in this study) in any other clinical study involving an investigational study intervention or any other type of medical research.\n13. Participants previously dosed in this study.\n14. Presence of HBsAg \\[or HBcAb\\] at screening or within 3 months prior to first dose of study intervention.\n15. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.\n16. Positive hepatitis C RNA (ribonucleic acid) test result at screening or within 3 months prior to first dose of study intervention.\n17. Positive pre-study drug\u002Falcohol screen.\n18. Positive HIV antibody test.\n19. Carbon monoxide levels indicative of smoking or more than 10 pack year history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.\n20. Use of known recreational drugs or drugs of abuse.\n21. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in the study.\n22. A positive confirmation of COVID-19 infection according to local procedures.",{"count":197,"type":22},156,[25],"The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.",[28],[202,120,31,203,204,205,206,207],"First time in human","GSK4024484","Healthy adults","Food effect","Single oral doses","Multiple oral doses","2026-03-26",{"date":210,"type":40},"2026-04-01",{"date":212,"type":40},"2023-12-11",{"date":214,"type":22},"2026-08-07",{"name":45,"class":46},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":224,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":229,"conditions":230,"keywords":234,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100587069","phase-3-serological-testing-and-treatment-for-plasmodium-vivax-malaria-a-trial-in-ethiopia-and-madagascar-100587069","NCT06923592","Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar","Serological Testing and Treatment for Plasmodium Vivax Malaria: a Cluster-Randomised Trial in Ethiopia and Madagascar","PvSTATEM","Inclusion Criteria:\n\n* Participant will remain in the study area for at least the next month.\n* Participant is older than 12 months\n\nExclusion Criteria:\n\n• Participant is unwilling to participate.","12 Months",{"count":226,"type":22},19200,[228],"PHASE3","The resilience of P. vivax to malaria elimination efforts is due to its ability to form dormant liver stages (hypnozoites) that reactivate weeks to months after the initial infection causing recurrent episodes of malaria (relapses) and ongoing parasite transmission. Relapses account for a majority of recurrent infections and clinical cases of P. vivax malaria, and therefore have a significant effect on morbidity at the individual level.\n\nWith current technology, it is not possible to directly measure hypnozoite biomarkers. Rather than directly detecting hypnozoites, our team developed an indirect approach by measuring antibodies induced by the primary blood-stage infection. Antibodies to different blood-stage antigens decay at different rates. Measuring antibodies to a carefully selected panel of P. vivax antigens can aid to identify individuals who have been infected within the previous 9 months (approximately the lifespan of hypnozoites).\n\nA serological test based on selected P. vivax antigens can detect recent exposure and predict future relapses. Coupling this test with a safe and efficacious primaquine treatment regimen, results in a population-based intervention to target the hypnozoite reservoir. This intervention is referred to as Plasmodium vivax Serological Testing and Treatment (PvSeroTAT).\n\nPvSTATEM is a cluster randomised trial in Madagascar and Ethiopia. This study will provide insights into the feasibility, acceptability, and efficacy of the PvSeroTAT approach. In this study, individuals, randomised by clusters, will be tested for the presence of serological markers of a recent P. vivax infection, followed by a targeted drug treatment intervention aimed at killing P. vivax hypnozoites.",[231,61,232,233],"Malaria Vivax","Plasmodium Vivax","Plasmodium Falciparum",[235,236,237,222,238,239,240,241],"Plasmodium vivax","Vivax","PvSeroTAT","Primaquine","serology","Cluster randomised trial","G6PD","2026-03-19",{"date":244,"type":40},"2026-03-24",{"date":246,"type":40},"2025-05-12",{"date":248,"type":22},"2027-04-28",{"name":250,"class":103},"London School of Hygiene and Tropical Medicine",2,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":16,"sex":17,"minAge":259,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":264,"conditions":265,"keywords":268,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":76},"100622856","assessing-the-feasibility-of-combining-dihydroartemisinin-piperaquine-and-primaquine-for-malaria-mass-drug-administration-in-high-endemic-communities-in-the-eastern-region-of-ghana-100622856","NCT07389057","Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of Ghana","Implementation Research to Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of Ghana","Inclusion Criteria:\n\n* must be aged 3 months and above and\n* be resident in the communities for the period of the study,\n* completed and signed a consent form from the parent or guardian of children below 18 years\n* Completed and signed assent for 12-17 years old children.\n* Completed and signed consent for those from age 18 years and above.\n\nExclusion Criteria:\n\n* Pregnant women\n* individual with a life-threatening illness (excluding malaria)\n* less than 10Kg body weight (or less than 1 year old)\n* individuals who had experienced adverse effects related to primaquine or\n* known to be G6PD deficient .","3 Months",{"count":261,"type":22},9000,[263],"NA","Previous malaria control studies in Ghana have shown that community-wide approaches can substantially reduce malaria infections. In a mass testing, treatment and tracking (MTTT) study, more than 75% of people in target communities were reached, leading to a 24% reduction in asymptomatic malaria after one year. However, rapid diagnostic tests (RDTs) can miss very low-level infections, meaning some infected individuals are not treated and can continue to spread malaria.\n\nA pilot malaria mass drug administration (MDA) study using artemether-lumefantrine (AL) in the Eastern Region of Ghana showed a very large reduction (over 95%) in parasite carriage after repeated rounds of treatment. Despite this success, malaria infections later fluctuated, possibly because some parasites remained in mosquitoes and because mature gametocytes-the parasite stage responsible for transmission-are not fully eliminated by standard malaria medicines.\n\nTo better interrupt malaria transmission, this study will use MDA with dihydroartemisinin-piperaquine (DHAP) combined with a single low dose of primaquine (PQ), which targets these transmission stages. The intervention will be given to the whole community every two months (six times per year) and compared with the current standard malaria control measures.\n\nThe study will examine whether this approach reduces malaria parasite carriage, whether malaria returns after treatment stops, and whether repeated MDA affects malaria drug resistance markers in the population. This two-year implementation research will generate practical evidence to guide national malaria policy in Ghana and inform the potential use of MDA in other malaria-endemic African countries.",[266,61,147,267],"Malaria Asymptomatic Parasitaemia","Malaria Transmission",[91,269,270,271,272],"Mass drug administration","Ghana","Feasibility","Implementation Research","2026-01-30",{"date":275,"type":40},"2026-02-05",{"date":277,"type":40},"2023-11-01",{"date":279,"type":22},"2026-11-30",{"name":281,"class":103},"Noguchi Memorial Institute for Medical Research",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":16,"sex":17,"minAge":289,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":303,"locationsCount":76},"100617703","phase-4-perennial-malaria-chemoprevention-in-the-malaria-vaccine-era-100617703","NCT07322068","Perennial Malaria Chemoprevention in the Malaria Vaccine Era","PMC-VAC","Inclusion Criteria:\n\n* Residency in Busia District, Uganda\n* Provision of informed consent by the parent\u002Fguardian for her child\n* Agreement to come to the study clinic for any febrile episode or other illness and avoid, where possible, medications given outside the study protocol\n\nExclusion Criteria:\n\n* Intention of permanently moving outside Busia district during the study period\n* Active medical problem requiring inpatient evaluation or chronic medical condition requiring frequent medical attention at the time of screening\n* Evidence of sickle cell disease (Hemoglobin SS genotype)\n* Biological mother known to be HIV positive","1 Day","10 Weeks",{"count":292,"type":22},1290,[294],"PHASE4","Malaria remains a major cause of pediatric deaths and morbidity in Africa. An affordable malaria vaccine, R21, is being deployed in Uganda and other African countries with high malaria transmission, but efficacy is incomplete and wanes rapidly, and R21 does not provide protection until infants complete the primary vaccination series, or \\~9 months of age. The goal of this study is to see whether combining R21 vaccination with two novel perennial malaria chemoprevention regimens can enhance protection against malaria compared with R21 alone. This study will take place at Masafu General Hospital (MGH) in Busia District, a rural area in Southeastern Uganda bordering Lake Victoria.",[28],"2026-01-06",{"date":299,"type":40},"2026-01-07",{"date":162,"type":22},{"date":302,"type":22},"2033-06",{"name":304,"class":103},"Stanford University",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":76},"100583853","phase-1-experimental-malaria-infection-of-healthy-malaria-naive-adults-by-mosquito-bite-with-the-genetically-modified-plasmodium-falciparum-nf54igp3-gap-100583853","NCT06881732","Experimental Malaria Infection of Healthy Malaria-Naive Adults by Mosquito Bite With the Genetically Modified Plasmodium Falciparum NF54\u002FiGP3 GAP","iGP3-SWITCH","INCLUSION CRITERIA:\n\n* Able and willing to complete the informed consent process\n* Available for the entire planned study duration\n* Male or Female\n* Aged 18 to 55 years\n* Willing to have blood samples collected, stored indefinitely and used for research purposes\n* Willing to defer blood donations for at least six months after the EoS visit (D180)\n* Agreement to adhere to specific Lifestyle Considerations throughout study duration\n\nClinical Criteria:\n\n* Total body weight ≥ 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg\u002Fm2 (inclusive)\n* In good general physical and mental health as evaluated through a comprehensive clinical assessment\n* Vital signs at screening and pre-inoculation within normal clinical range\n* Electrocardiograph (ECG) without significant abnormalities, including: QTcF ≤450 ms for males, QTcF ≤470 ms for females, PR interval ≤210 ms\n\nLaboratory Criteria:\n\n* O negative blood type\n* Haemoglobin, white cell count and platelet levels within normal laboratory ranges\n* Ferritin, creatinine and alanine aminotransferase (ALT) within normal laboratory ranges\n* No clinically significant abnormality in coagulation or clotting\n* Normal G6PD enzyme activity levels as defined by the parameters of the specific quantitative G6PD test performed at screening\n* Negative for blood borne viruses, including Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human T-lymphotropic virus type 1 (HTLV); and other blood borne pathogens including West Nile Virus (WNV), Babesia species, Treponema pallidum, and Trypanosoma cruzi\n\nCriteria specific to female participants:\n\n* Post-menopausal for at least 1 one year, post-hysterectomy, or bilateral oophorectomy with a correlating follicle stimulating hormone (FSH) level.\n\nOR\n\n* Females of childbearing age have a negative beta-human chorionic gonadotrophin (b-HCG) pregnancy test (urine or serum) on day of enrolment and prior to CHMI inoculation and agreement to use effective birth control through the duration of the study.\n\nEXCLUSION CRITERIA:\n\n* Participant lives alone and is unable provide contact details of a support person who is aware of the individual's participation in the study and is available to provide assistance if required\n* Participation in any investigational product study within the 12 weeks preceding inoculation\n* Positive urine drug test at screening or on the day of malaria inoculation unless there is an explanation acceptable to the Investigator (e.g. the volunteer has stated in advance that they consumed a prescription or over-the-counter product which contained the detected drug) and\u002For the volunteer has a negative urine drug screen on retest by the pathology laboratory\n* Positive alcohol breath test at screening or on the day of malaria inoculation\n\nMalaria History:\n\n* Any previous history of malaria infection, including participation in a malaria research study\n* Receipt of a malaria vaccination at any time, including as part of a research study\n* Travelled to or lived (more than two weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region over the course of the study\n* Lived for more than one year in a malaria-endemic region in the past 10 years\n* Lived in a malaria-endemic region for more than 10 years inclusive\n\nClinical History:\n\n* Anyone who is pregnant, breastfeeding or planning pregnancy during the study period\n* History of severe allergic reaction, including angioedema or anaphylaxis\n* Receipt of any live attenuated vaccines within 21 days prior to enrolment\n* Has ever received a blood transfusion\n* Use of blood products or immunoglobulins within the previous 6 months\n* Without good peripheral venous access\n* Clinical history of: Sickle cell disease, sickle cell trait or other haemoglobinopathies; Splenectomy or fuctional asplenia; Skeeter syndrome or anaphylactic response to mosquito bites\n* Known intolerance, hypersensitivity or other contraindication to artemether or other artemisinin derivatives, lumefantrine, atovaquone, proguanil, primaquine, or artesunate or any of its excipients\n* Use or planned use of any drug, including antibiotics, with antimalarial activity four weeks prior to inoculation\n* Use of any of the following drugs: Anticoagulants (within 14 days of enrolment); Systemic corticosteroids (within 3 months of enrolment); Any prescription or non-prescription drugs, and or supplements that in the opinion of the investigator would jeopardise the safety of the volunteer\n* Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, infectious diseases, psychiatric disorders, heart disease, or cancer\n\nClinical Risk:\n\n* Evidence at screening of increased cardiovascular disease risk (defined as \\>10%, 5-year risk for those greater than 35 years of age), as determined by the Australian Absolute Cardiovascular Disease Risk Calculator",{"count":251,"type":22},[25],"The goal of this clinical trial is to learn if the genetically-modified malaria parasite NF54\u002FiGP3 will safely infect humans with malaria. The investigators will also determine how the parasite grows in humans, and the effect of anti-malarial drugs.\n\nResearchers will use a controlled human malaria infection (CHMI) model to infect participants with malaria to observe the development of the disease, collect malaria-infected blood, and then treat the participants to cure the malaria infection.\n\nThe collected malaria-infected blood will be used to create a frozen stock of malaria parasites for use in future research.",[61,147,267],[317,318,64],"SWITCH","NF54\u002FiGP3","2025-03-11",{"date":321,"type":40},"2025-03-18",{"date":323,"type":22},"2025-07",{"date":325,"type":22},"2026-07",{"name":327,"class":103},"University of Melbourne"]