A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM17321 in Healthy and Obese Participants
Hanmi Pharmaceutical Company Limited
90 participants
Nov 6, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria18
- 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 (whichever is longer) prior to screening.
- HbA1c ≥6.5% or a history of diabetes mellitus (type 1 or type 2).
- Obesity induced by other endocrine disorders (e.g., Cushing syndrome).
- Use of weight control treatments (e.g., GLP-1 receptor agonists or other anti-obesity medications) and antihypertensive medications within 3 months prior to screening.
- Use of any lipid-lowering medications, unless on a stable dose for at least 3 months prior to screening.
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Interventions
Participants will receive a single or multiple subcutaneous injections of HM17321 at the assigned dose level. HM17321 is provided as a sterile solution in prefilled syringes.
Participants will receive a single or multiple subcutaneous injections of a matching placebo solution in prefilled syringes. The placebo does not contain any active ingredients.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07219589