A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants (NCT07219589) | Clinical Trial Compass
RecruitingPhase 1
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
United States90 participantsStarted 2025-11-06
Plain-language summary
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single and multiple ascending doses in healthy and obese participants.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18-65 years.
* Part A: Healthy participants with BMI ≥20 kg/m² and ≤27 kg/m² at screening.
* Part B: Healthy obese participants with BMI ≥30 kg/m² and ≤45 kg/m² at screening.
* Stable body weight (\<5% change) in the past 3 months.
* Able and willing to provide written informed consent.
* Male participants must use contraception or remain abstinent from women of childbearing potential.
* Female participants must not be pregnant or breastfeeding and use highly effective contraception if of childbearing potential.
Exclusion Criteria:
* History of any bariatric procedure.
* Uncontrolled thyroid disease (TSH \>6.0 or \<0.4 mIU/L).
* Abnormal liver function or clinically significant liver disease
* Part A: ALT or AST ≥ ULN, or total bilirubin ≥ ULN
* Part B: ALT or AST \>2× ULN, or total bilirubin \>1.5× ULN
* Abnormal pancreatic function
* Part A: amylase or lipase ≥ ULN
* Part B: amylase or lipase \>3× ULN
* Clinically significant cardiovascular disorders (e.g., myocardial infarction, congestive heart failure, long QT syndrome).
* Abnormal renal function (eGFR \<60 mL/min/1.73 m²).
* Positive test for hepatitis B, hepatitis C, or HIV at screening.
* Women who are pregnant, planning to become pregnant, or breastfeeding.
* History of drug or alcohol abuse within defined timeframes (e.g., alcohol \>14 standard units/week in past year, or positive drug screen).
* Use of any investigational product within 30 days or 5 half-lives (whichev…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321
Timeframe: Up to Day 29 (Part A); Up to Day 113 (Part B)