RecruitingPhase 1NCT07219589

A Single Ascending Dose Study of HM17321 in Healthy Adult Participants

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM17321 in Healthy Adult Participants

Sponsor

Hanmi Pharmaceutical Company Limited

Enrollment

40 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Obese

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria10

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.

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Interventions

DRUGHM17321

Participants will receive a single subcutaneous injection of HM17321 at the assigned dose level. HM17321 is provided as a sterile solution in prefilled syringes.

DRUGPlacebo of HM17321

Participants will receive a single subcutaneous injection of a matching placebo solution in prefilled syringes. The placebo does not contain any active ingredients.