[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pulmongene Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100640390","phase-1-a-study-to-test-the-safety-and-blood-levels-of-pmg1016-in-healthy-adults-100640390",false,"NCT07615985","Phase 1a Study Assessing Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016","A Phase 1a, First-in-human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016 in Healthy Volunteers","Inclusion Criteria:\n\n* Participants must be in good health based on medical history, physical exam, vital signs, ECG, and lab results at screening, as judged by the PI.\n* BMI 17.5-32.0 kg\u002Fm² and body weight 50-100 kg for males or 45-100 kg for females\n* No clinically significant lab abnormalities (hematology, coagulation, biochemistry, urinalysis) per PI discretion\n* Females: Must be non-pregnant, non-lactating, and use double contraception (condom + hormonal method\u002Fvaginal ring\u002FIUD) through study completion, unless surgically sterile, postmenopausal, or in same-sex relationships. Negative pregnancy tests required. No oocyte donation for 90 days post dose.\n* Males: Must be surgically sterile, abstinent, or use condoms plus a highly effective method for female partners. Vasectomized males without proof of azoospermia must use condoms with WOCBP partners. No sperm donation for 90 days post dose.\n\nExclusion Criteria:\n\n* History or evidence of any clinically significant medical condition (e.g., cardiovascular, gastrointestinal, endocrine, hematologic, psychiatric, renal, musculoskeletal, infectious, neurological, or other major disease) as determined by the PI.\n* A PR \\\u003C40 or \\>100 bpm or mean SBP \\>140 mmHg or DBP \\>95 mmHg (based on triplicate supine measurements after 5 minutes' rest).\n* Mean QTcF \\>450 ms (males) or \\>470 ms (females) at Screening; one repeat triplicate ECG allowed at PI discretion\n* Any clinically significant ECG abnormalities (rhythm, conduction, morphology) that may affect QTc interpretation, per PI judgment\n* ALT, AST, or creatinine \\>1.5 × ULN, or total bilirubin or lymphocytes \\> ULN.\n* Hemoglobin (HGB) below the lower limit of the normal range (ULN) prior to enrollment.\n* Participants with a positive toxicology screening panel or positive alcohol breath test at Screening and on Day -1.\n* Regular alcohol consumption defined as \\> 21 alcohol units per week. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and while residing at the CRU.\n* Blood donation or significant blood loss (≥500 mL) within 60 days prior to the first IP administration.\n* Plasma donation within 7 days prior to the first IP administration.\n* Use of any investigational product\u002Fdevice within 30 days or 5 half-lives (whichever is longer), or participation in \\>4 investigational drug studies in the past year.\n* Pregnant or lactating at Screening or planning pregnancy (self or partner) during the study or follow-up.\n* Fever \\>37.5°C or symptomatic infection within 2 weeks before Screening; any infection requiring systemic antibiotics within 3 months; history of recurrent infections; or a positive SARS-CoV-2 PCR before CRU admission.\n* Active malignancy, history of malignancy, or untreated precancerous lesions. Adequately treated or fully excised precancerous lesions are allowed.\n* Participants with a known history of retinal diseases, including conditions such as prior retinal detachment.\n* Participants with a history of recurrent epistaxis or gingival bleeding.\n* Use of prescription medications (except hormonal contraception) within 2 weeks before dosing; mAb products within 5 half-lives; or OTC drugs, supplements, or herbal products within 7 days before dosing.\n* History of anaphylaxis or severe allergy per PI judgment; mild untreated hay fever may be allowed.\n* History of allergic reaction or hypersensitivity to any of the excipients in the IP.\n* Positive screening test for HIV-1\u002F2, HBsAg, HCV antibody, or syphilis.\n* Any condition that, in the PI's judgment, may pose a risk to the participant or the study.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is a first-in-human (FIH), randomized, double-blind, placebo-controlled study of PMG1016 in healthy adult participants. It aims to investigate the safety, tolerability, PK, and immunogenicity of PMG1016 administered via IV infusion.\n\nCohort 1: Healthy participants receiving single doses of PMG1016 Dose 1 or placebo.\n\nCohort 2: Healthy participants receiving single doses of PMG1016 Dose 2 or placebo.\n\nCohort 3: Healthy participants receiving single doses of PMG1016 Dose 3 or placebo.\n\nCohort 4: Healthy participants receiving single doses of PMG1016 Dose 4 or placebo.",[28],"Chronic Kidney Disease","RECRUITING","2026-09-18",{"date":32,"type":33},"2026-09-23","ACTUAL",{"date":35,"type":33},"2026-05-29",{"date":37,"type":22},"2026-11-30",{"name":39,"class":40},"Pulmongene Ltd.","INDUSTRY",""]