[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640390":3},{"organization":4,"outcomesModule":7,"designInfo":81,"detailedDescription":90,"studyPopulation":18,"armGroups":91,"interventions":109,"overallOfficials":18,"centralContacts":132,"locations":138,"responsibleParty":158,"collaborators":18,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":18,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":18,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":18,"overallStatus":141,"whyStopped":18,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Pulmongene Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":49,"otherOutcomes":18},[9,13,16,19,21,23,25,27,29,31,33,37,40,42,44,46],{"measure":10,"description":11,"timeFrame":12},"Treatment-emergent adverse events (TEAEs)","The incidence and severity occurred","Day 1 to Day 57",{"measure":14,"description":11,"timeFrame":15},"Serious adverse events (SAEs)","From Day 1 to Day 57",{"measure":17,"description":18,"timeFrame":15},"Number of participants with abnormal pulse rate",null,{"measure":20,"description":18,"timeFrame":15},"Number of participants with abnormal blood pressure",{"measure":22,"description":18,"timeFrame":15},"Number of participants with abnormal respiratory rate",{"measure":24,"description":18,"timeFrame":15},"Number of participants with abnormal tympanic temperature",{"measure":26,"description":18,"timeFrame":15},"Number of Participants with Clinically Significant Abnormal PR Interval",{"measure":28,"description":18,"timeFrame":15},"Number of Participants with Clinically Significant Abnormal QRS Duration",{"measure":30,"description":18,"timeFrame":15},"Number of Participants with Clinically Significant Abnormal QT interval",{"measure":32,"description":18,"timeFrame":15},"Number of Participants with Clinically Significant Abnormal RR interval",{"measure":34,"description":35,"timeFrame":36},"Number of Participants with Clinically Significant Valvular Abnormalities","The number of participants with clinically significant valvular abnormalities identified by transthoracic echocardiography (TTE)","Day 1 to Day 29",{"measure":38,"description":39,"timeFrame":36},"Number of Participants with Clinically Significant Abnormal Left Ventricular Ejection Fraction","The number of participants with clinically significant abnormalities in left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography (TTE)",{"measure":41,"description":18,"timeFrame":12},"Number of Participants with Clinically Significant Abnormal Hematology Results",{"measure":43,"description":18,"timeFrame":12},"Number of Participants with Clinically Significant Abnormal Clinical Chemistry Results",{"measure":45,"description":18,"timeFrame":12},"Number of Participants with Clinically Significant Abnormal Urinalysis Results",{"measure":47,"description":48,"timeFrame":12},"Number of Participants with Clinically Significant Abnormal Physical Examination Findings","assessment of general appearance; head; ears; eyes; nose; throat; dentition; thyroid; chest (heart and lungs); abdomen; skin; neurological system; extremities; back; neck; musculoskeletal system; and lymph nodes",[50,53,57,60,63,66,69,72,75,78],{"measure":51,"description":52,"timeFrame":15},"Incidence of anti-drug antibodies (ADA)","Percentage of PMG1016-induced ADA positive participants and percentage of PMG1016-boosted ADA positive participants",{"measure":54,"description":55,"timeFrame":56},"Maximum serum PMG1016 concentration (Cmax)","Determine PMG1016 Cmax in Serum","Varying timepoints through end of treatment, up to Day 57",{"measure":58,"description":59,"timeFrame":56},"Time to maximum concentration (Tmax)","Determine PMG1016 Tmax in Serum.",{"measure":61,"description":62,"timeFrame":56},"Area under the serum drug concentration-time curve (AUC) from time zero to the last time point with measurable concentration (AUC0-t)","Determine PMG1016 AUC and AUC0-t in Serum.",{"measure":64,"description":65,"timeFrame":56},"AUC from time zero to infinity (AUC0-∞)","Determine PMG1016 AUC0-∞ in Serum.",{"measure":67,"description":68,"timeFrame":56},"The extrapolated portion of AUC0-∞ from Tlast to infinity (%AUCextrap)","Determine PMG1016 %AUCextrap in Serum.",{"measure":70,"description":71,"timeFrame":56},"Terminal elimination half-life (t1\u002F2)","Determine PMG1016 t1\u002F2 in Serum.",{"measure":73,"description":74,"timeFrame":56},"Apparent total body clearance (CL)","Determine PMG1016 CL in Serum.",{"measure":76,"description":77,"timeFrame":56},"Apparent volume of distribution during the terminal phase (Vz)","Determine PMG1016 Vz in Serum.",{"measure":79,"description":80,"timeFrame":56},"Apparent terminal elimination rate constant (λz)","Determine PMG1016 λz in Serum.",{"allocation":82,"interventionModel":83,"interventionModelDescription":18,"primaryPurpose":84,"observationalModel":18,"timePerspective":18,"maskingInfo":85},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":86,"maskingDescription":18,"whoMasked":87},"DOUBLE",[88,89],"PARTICIPANT","INVESTIGATOR","Participants will be enrolled and randomized into 1 of 4 cohorts in a double-blind manner",[92,97,101,105],{"label":93,"type":94,"description":18,"interventionNames":95},"Cohort 1","EXPERIMENTAL",[96],"Drug: PMG1016 Dose 1",{"label":98,"type":94,"description":18,"interventionNames":99},"Cohort 2",[100],"Drug: PMG1016 Dose 2",{"label":102,"type":94,"description":18,"interventionNames":103},"Cohort 3",[104],"Drug: PMG1016 Dose 3",{"label":106,"type":94,"description":18,"interventionNames":107},"Cohort 4",[108],"Drug: PMG1016 Dose 4",[110,117,122,127],{"type":111,"name":112,"description":113,"armGroupLabels":114,"otherNames":115},"DRUG","PMG1016 Dose 1","Participants will be administered PMG1016 Dose 1 or Placebo in a 100mL IV infusion Volume",[93],[116],"PMG1016",{"type":111,"name":118,"description":119,"armGroupLabels":120,"otherNames":121},"PMG1016 Dose 2","Participants will be administered PMG1016 Dose 2 or Placebo in a 100mL IV infusion Volume",[98],[116],{"type":111,"name":123,"description":124,"armGroupLabels":125,"otherNames":126},"PMG1016 Dose 3","Participants will be administered PMG1016 Dose 3 or Placebo in a 100mL IV infusion Volume",[102],[116],{"type":111,"name":128,"description":129,"armGroupLabels":130,"otherNames":131},"PMG1016 Dose 4","Participants will be administered PMG1016 Dose 4 or Placebo in a 100mL IV infusion Volume",[106],[116],[133],{"name":134,"role":135,"phone":136,"phoneExt":18,"email":137},"Yaohui Wang","CONTACT","+86 13810669548","yaohui_wang@pulmongene.com",[139],{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"Nucleus Network (Brisbane)","RECRUITING","Brisbane","Queensland","4006","Australia","AU",{"type":148,"coordinates":149},"Point",[150,151],153.02809,-27.46794,{"lat":151,"lon":150},[154],{"name":155,"role":135,"phone":156,"phoneExt":18,"email":157},"Richard Friend, Dr","(07) 3707 2720","r.friend@nucleusnetwork.com.au",{"type":159,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":172,"type":173},30,"ESTIMATED","INTERVENTIONAL",[176],"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.",[179],"Chronic Kidney Disease","2026-09-18",{"date":182,"type":183},"2026-09-23","ACTUAL",{"date":185,"type":183},"2026-05-29",{"date":187,"type":173},"2026-11-30",{"name":5,"class":6},1]