Status:
RECRUITING
A SAD Study of HM17321 in Healthy Adult Participants
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Obesity
Obese
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single ascending doses in healthy adult participants.
Detailed Description
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 in healthy...
Eligibility Criteria
Inclusion
- Adults aged 18-65 years.
- BMI ≥20 kg/m² and ≤27 kg/m².
- 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 effective contraception if of childbearing potential.
Exclusion
- History of any bariatric procedure.
- Uncontrolled thyroid disease (TSH \>6.0 or \<0.4 mIU/L).
- Abnormal liver function tests (ALT or AST \>2×ULN, or total bilirubin \>1.5×ULN) or severe active liver disease.
- Abnormal pancreatic function (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 (whichever is longer) prior to screening.
Key Trial Info
Start Date :
November 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07219589
Start Date
November 6 2025
End Date
April 1 2026
Last Update
November 13 2025
Active Locations (1)
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1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227