[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medicines for Malaria Venture\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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",false,"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",true,"ALL","18 Years","60 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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],"Malaria, Falciparum",[30,31,32],"Malaria","First In Human","Healthy Volunteers","RECRUITING","2026-06-12",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":37},"2025-06-30",{"date":41,"type":22},"2027-12-02",{"name":43,"class":44},"Medicines for Malaria Venture","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":45},"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":56,"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).",[60,61,62,63,64,30,65],"Malaria (Plasmodium Falciparum)","Malaria Falciparum","Malaria Infection","Malaria Prophylaxis","Malaria Prevention","Malaria Parasitaemia",[67,68,69,70,71,72],"malaria prevention","malaria prophylaxis","malaria falciparum","Malaria infection","Malaria Long-Acting Injectable","Long-Acting Injectable","NOT_YET_RECRUITING","2026-04-17",{"date":76,"type":37},"2026-04-23",{"date":78,"type":22},"2026-09",{"date":80,"type":22},"2028-03",{"name":43,"class":44},""]