[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Traws Pharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,69],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100633424","phase-1-study-of-trx-100-tablets-evaluating-the-safety-pharmacokinetics-and-food-effect-in-healthy-volunteers-100633424",false,"NCT07526506","Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers","A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect of Single Ascending Doses of TRX-100 in Healthy Volunteers","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.\n2. Adult males and females, 18 to 65 years of age (inclusive) at screening.\n3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg\u002Fm2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.\n4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit, including:\n\n   1. Physical examination without any clinically significant findings in the opinion of the investigator.\n   2. Systolic blood pressure in the range of 90 mm Hg to 149 mm Hg; diastolic blood pressure in the range of 50 mm Hg to 90 mm Hg after 5 minutes in a supine or semi-supine position.\n   3. Heart rate (HR) in the range of 40 to 100 bpm after 5 minutes in a supine position\n   4. Body temperature (tympanic or oral) in the range 35.5°C to 37.5°C (inclusive).\n   5. No clinically significant findings in serum chemistry, hematology, coagulation, and urinalysis tests as judged by the Investigator, including the following specific findings:\n\n   i. Haemoglobin, platelet count, WBC count, lymphocyte count, and neutrophil count within normal ranges (as per local laboratory standard ranges) or out-of-range values deemed not clinically significant (NCS) by the Investigator.\n\n   ii. AST, ALT and total bilirubin \\\u003C 1.5 x ULN (note: for participants with Gilbert's syndrome, ULN for total bilirubin is considered to be 2.9 mg\u002FdL).\n\n   iii. Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities.\n\n   iv. Hemoglobin A1C (HbA1c) level within the local laboratory standard reference range\n5. Be willing to refrain from smoking (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 1 to Day 12 (inclusive).\n6. Be willing to abstain from alcohol consumption at least 48 hours prior to dosing on Day -1 and throughout the study.\n7. Female volunteers must:\n\n   1. Be of nonchildbearing potential, i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before screening or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level \\>40 IU\u002FL at the screening visit), or\n   2. If of childbearing potential, must:\n\n   i. Have a negative pregnancy test at the screening visit and on admission to the clinic on Day-1.\n\n   ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 30 days after the last dose of the study drug.\n\n   iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from one month prior to screening until at least 30 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.\n8. Male volunteers must:\n\n   1. Agree not to donate sperm from signing the consent form until at least 90 days after the last dose of study drug.\n   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the consent form until at least 30 days after the last dose of study drug.\n9. Have suitable venous access for blood sampling.\n10. Be willing and able to comply with all study assessments and adhere to the protocol.\n\nExclusion Criteria:\n\n1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.\n2. History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.\n3. Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.\n4. Presence or history of any abnormality or illness, including gastrointestinal surgery, liver, kidney, or other conditions, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.\n5. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).\n6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.\n7. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids by any route, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study and within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to dosing.\n8. Use of or plans to use agents (e.g., grapefruit and grapefruit products) that have clinically significant interaction with CYP3A4 or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine) during the study and within 5 half-lives of individual agent or within 7 days (whichever is longer) prior to dosing.\n9. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or clinically significant arrythmia.\n10. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies at the screening visit.\n11. Estimated creatinine clearance \\\u003C 60 mL\u002Fmin using the Cockcroft-Gault formula at the screening visit.\n12. Creatine kinase \\>2 x ULN at Day -1.\n13. History of any drug or alcohol abuse in the past 2 years defined as \\>21 units of alcohol per week for males and \\>14 units of alcohol per week for females. Where 1 unit = 360 mL of beer, 150 mL wine, or 30 mL of spirits.\n14. Positive drugs of abuse or alcohol breath test results at the screening visit or on Day -1.\n15. Use of any prescription medications or any over-the-counter medication (including herbal products, nutritional, calcium-enriched dietary supplements, antacids, laxatives, minerals and hormone supplements) within 14 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration and during the study, with the exception of oral, injectable and implanted contraceptives, occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days) or ibuprofen (doses of 400 mg up to every 6 hours or 1.2 g per day maximum for no more than 3 consecutive days), topical ointments, vitamins, dietary supplements and medications used to manage AEs.\n16. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.\n17. Known hypersensitivity to any of the study drug ingredients.\n18. Use of any inactivated vaccinations within 14 days, or any live vaccinations within 30 days prior to the first study drug administration and during the study. Note: Participants vaccinated for COVID-19 or influenza within at least 2 weeks prior to dosing or earlier will be considered eligible for enrolment as long as they do not present with post-vaccination clinical symptoms, have a negative rapid antigen test (in the case of COVID-19), and are deemed otherwise healthy.\n19. Females who are breastfeeding or planning to breast feed at any time during the study.\n20. Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration.\n21. Receiving an investigational drug in another clinical trial within 30 days or 5 half-lives of the investigational agent (whichever is longer) prior to the first study drug administration.\n22. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.\n23. Any history of long-COVID infection (defined by continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation).\n24. Any history of severe influenza, defined as a confirmed diagnosis of influenza resulting in hospitalization, or symptoms severe enough to disrupt daily activities for more than 7 consecutive days.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1b, randomized, double-blind, placebo-controlled, dose escalation study of TRX-100 tablets evaluating the safety, pharmacokinetics, and food effect of single ascending doses of TRX-100 in healthy volunteers.",[28],"Healthy Volunteer",[30,31],"Influenza","Flu","RECRUITING","2026-04-06",{"date":35,"type":36},"2026-04-13","ACTUAL",{"date":38,"type":36},"2026-03-25",{"date":40,"type":22},"2027-02",{"name":42,"class":43},"Traws Pharma, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100631647","phase-2-phase-2a-study-of-the-efficacy-and-safety-of-trx-100-in-a-human-influenza-a-challenge-model-100631647","NCT07503405","Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model","A Phase 2a, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tivoxavir Marboxil (TRX-100) in Healthy Adults in a Human Influenza A Challenge Model","Inclusion Criteria:\n\n1. Written informed consent signed and dated by the participant and the PI\u002Finvestigator obtained before any assessment is performed.\n2. Aged between 18 and 55 years old on the day prior to signing the consent form, inclusive.\n3. A total body weight ≥50 kg and body mass index (BMI) ≥18 kg\u002Fm2 and ≤35kg\u002Fm2.\n4. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the PI\u002Finvestigator.\n5. Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.\n6. The following criteria are applicable to female participants participating in the study:\n\n   1. Females of childbearing potential must have a negative pregnancy test prior to enrollment.\n   2. Females of non-childbearing potential:\n\n   \u003C!-- -->\n\n   1. Postmenopausal females defined as amenorrhea for 12 months or greater with no alternative medical cause. A high follicle-stimulating hormone (FSH) level, within appropriate postmenopausal range, may be used to confirm postmenopausal state in the absence of combined hormonal contraception or hormone replacement therapy. If there is less than 12 months of amenorrhea 2 FSH samples are required at least 4 to 6 weeks apart.\n   2. Documented status as being permanently sterile (e.g., hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).\n7. Female participants of childbearing potential must use one form of highly effective contraception (birth control). Hormonal methods must be in place from at least 2 weeks prior to the first study visit (IMP administration visit). The contraception use must continue until 28 days after the date of challenge agent administration.\n\n   Male participants must agree to use one of the contraceptive requirements below from the first study visit and continuing until 28 days after the date of challenge agent administration.\n8. Serosuitable for the challenge agent. The serology result obtained from the influenza antibody assay suggests that the participant is sensitive to influenza infection (i.e., they are likely to be infected following inoculation with the challenge agent).\n\nExclusion Criteria:\n\n1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.\n2. Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, hematologic, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and\u002For other major disease that, in the opinion of the PI\u002Finvestigator, may interfere with a participant completing the study and necessary investigations. The following conditions apply:\n\n   1. Participants with a history of resolved depression and\u002For anxiety may be included at the discretion of the PI\u002Finvestigator. Participants with a history of stress-related illness, which is not ongoing or requiring current therapy, with good evidence of preceding stressors may also be included at the PI\u002Finvestigator's discretion. As required, participants will be assessed prior to enrollment with a Patient Health Questionnaire (PHQ)-9 and\u002For Generalized Anxiety Disorder (GAD)-7 questionnaire which must score ≤4 on admission.\n   2. Rhinitis (including hay fever) which is clinically active or a history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and\u002For requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI\u002Finvestigator's discretion.\n   3. Atopic dermatitis\u002Feczema which is clinically severe and\u002For requiring moderate to large amounts of daily dermal corticosteroids will be excluded. Participants with mild to moderate atopic dermatitis\u002Feczema, taking small amounts of regular dermal corticosteroids may be included at the PI\u002Finvestigator's discretion.\n   4. Any concurrent serious illness including history of malignancy that may interfere with a participant completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.\n   5. Participants reporting physician-diagnosed migraine can be included provided there are no associated neurological symptoms such as hemiplegia or visual loss. Cluster headache\u002Fmigraine or prophylactic treatment for migraine is an exclusion.\n   6. Participants with physician-diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the PI\u002Finvestigator's discretion.\n3. Any participants who have smoked ≥10 pack years at any time (10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years) including (as applicable) any calculable or self-reported significant vaping history.\n4. Females who:\n\n   1. Are breastfeeding, or\n   2. Have been pregnant within 6 months prior to the study, or\n   3. Have a positive pregnancy test at any point during screening or prior to dosing with IMP.\n5. Lifetime history of anaphylaxis and\u002For a lifetime history of severe allergic reaction. Significant intolerance to any food or drug in the last 12 months, as assessed by the PI\u002Finvestigator.\n6. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.\n7. a) Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or challenge agent administration (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and\u002For requiring regular treatments in the last month will be excluded).\n\n   b) Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and\u002For history of being hospitalized due to epistaxis on any previous occasion.\n\n   c) Any nasal or sinus surgery within 3 months of the first study visit.\n8. a) Evidence of vaccinations within the 4 weeks prior to the planned date of dosing with IMP.\n\n   b) Intention to receive any vaccination(s) before the last day of follow-up. c) Receipt of influenza vaccine in the last 180 days prior to the planned date of viral challenge.\n\n   d) Received antiviral medication for influenza in the last 180 days prior to the planned date of viral challenge.\n\n   e) Having had confirmed influenza illness in the last 180 days prior to the planned dosing of IMP.\n9. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned date of dosing with IMP or planned during the 3 months after the final follow-up visit.\n10. a) Receipt of any investigational drug within 3 months or 5 half-lives (whichever is greater) prior to the planned date of dosing with IMP.\n\n    b) Receipt of ≥3 investigational drugs within the previous 12 months prior to the planned date of dosing with IMP.\n\n    c) Prior inoculation with a virus from the same virus-family as the challenge agent.\n\n    d) Prior participation in another human challenge study with a challenge agent in the preceding 3 months, taken from the date of challenge agent administration in the previous study to the date of expected challenge agent administration in this study.\n11. Use or anticipated use during the conduct of the study of concomitant medications (prescription and\u002For non-prescription), including vitamins or herbal and dietary supplements within the specified windows, unless in the opinion of the PI\u002Finvestigator, the medication will not interfere with the study procedures or compromise participant safety. Specifically, the following are excluded:\n\n    1. Herbal supplements within 7 days prior to the planned date of dosing with IMP.\n    2. Chronically used medications, vitamins, or dietary supplements, including any medications known to be potent inducers or inhibitors of CYP450 enzymes, within 21 days prior to the planned date of dosing with IMP.\n    3. Over the counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 7 days prior to the planned date of dosing with IMP has exceeded the maximum permissible 24-hour dose (e.g., ≥4 g paracetamol over the preceding week).\n    4. Systemic antiviral administration within 4 weeks of the dosing with IMP.\n12. a) Confirmed positive test for drugs of misuse on first study visit (i.e., IMP administration visit). One repeat test is allowed at PI\u002Finvestigator's discretion.\n\n    b) Recent history or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine or a measure of spirits).\n\n    c) Excessive consumption of xanthine-containing substances (e.g., daily intake in excess of 5 cups of caffeinated drinks e.g., coffee, tea, cola).\n\n    d) Presence of significant signs and symptoms of nicotine withdrawal on entry to the clinical unit.\n13. A forced expiratory volume in 1 second (FEV1) \\\u003C 80%.\n14. Positive HIV, hepatitis B, or hepatitis C test.\n15. Presence of fever, defined as participant presenting with a temperature reading of ≥37.9ºC on Day -2, Day -1, and\u002For pre-challenge on Day 0.\n16. Those employed or immediate relatives of those employed at hVIVO or the sponsor.\n17. Any other medical, psychiatric, social, or occupational condition and\u002For responsibility that, in the opinion of the PI\u002Finvestigator, would interfere with, or serve as a contraindication to, protocol adherence or the assessment of safety (including reactogenicity) will deem the participant unsuitable for the study.\n\nAny other reason that in the opinion of the PI\u002Finvestigator raises a concern that the participant will not be able to cope with quarantine requirements.","55 Years",{"count":54,"type":22},165,[56],"PHASE2","This will be a randomized, double-blind, placebo-controlled proof of concept study to evaluate the prophylactic efficacy and safety of orally administered TRX-100 in healthy adults challenged with influenza A\u002FFrance\u002F759\u002F2021 (H1N1) virus.",[30],[60],"Challenge study","NOT_YET_RECRUITING",{"date":63,"type":36},"2026-03-31",{"date":65,"type":22},"2026-06",{"date":67,"type":22},"2027-04",{"name":42,"class":43},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100605014","phase-2-early-stage-trial-to-determine-a-safe-and-effective-dose-for-ratutrelvir-in-patients-with-mild-to-moderate-covid-19-100605014","NCT07157007","Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19","A Multicenter, Open-Label, Randomized Phase 2a Study to Evaluate Safety and Efficacy of Ratutrelvir and Standard of Care in Non-hospitalized Symptomatic Adult Participants With Mild to Moderate COVID-19","Inclusion Criteria:\n\n1. Confirmed SARS-CoV-2 infection for 120 h prior to randomization.\n2. Initial onset of signs\u002Fsymptoms attributable to COVID-19 within 5 days prior to randomization.\n3. At least one of the symptoms attributable to COVID-19 present within 24 hours prior to the Day 1 with the severity score of 1 or higher according to the following scoring system for the assessment of severity of:\n\nExclusion Criteria:\n\nMedical Conditions:\n\n1. History, current need for hospitalization or anticipated need for hospitalization for the medical treatment of COVID-19.\n2. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.\n3. Known medical history of active liver disease .\n4. Receiving dialysis or history of moderate to severe renal impairment.\n5. Compromised immune system.\n6. Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease within 30 days before screening.\n7. Suspected or confirmed concurrent active systemic infection..\n\n   Prior\u002FConcomitant Therapy:\n8. Has received or is expected to receive any dose of a SARS-CoV-2 vaccine within 4 months of screening and during the participation in the study.\n9. Concomitant use of any medications or substances that are strong inducers of CYP3A4",{"count":77,"type":22},90,[56],"This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19. It will also learn about the safety of drug Ratutrelvir. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.",[81],"COVID - 19","2026-01-17",{"date":84,"type":36},"2026-01-21",{"date":86,"type":36},"2025-09-16",{"date":88,"type":22},"2026-03",{"name":42,"class":43},15,""]