Actively Recruiting
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-05-04
90
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years
- Part A: Healthy participants with BMI 20 kg/m and 27 27 kg/m at screening
- Part B: Healthy obese participants with BMI 30 kg/m and 45 kg/m 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
You will not qualify if you...
- 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 26 ULN, or total bilirubin 26 ULN; Part B: ALT or AST >2�d7 ULN, or total bilirubin >1.5�d7 ULN
- Abnormal pancreatic function: Part A: amylase or lipase 26 ULN; Part B: amylase or lipase >3�d7 ULN
- Clinically significant cardiovascular disorders such as myocardial infarction, congestive heart failure, or long QT syndrome
- Abnormal renal function (eGFR <60 mL/min/1.73 m)
- 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 prior to screening
- Additional Exclusion for Part B: HbA1c 26 6.5% or history of diabetes mellitus
- Obesity caused by other endocrine disorders (e.g., Cushing syndrome)
- Use of weight control treatments or 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Actively Recruiting
Research Team
J
Jimin Han
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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