A SAD Study of HM17321 in Healthy Adult Participants

Hanmi Pharmaceutical

Status and phase

Enrolling

Phase 1

Conditions

Obese

Obesity

Treatments

Drug: Placebo of HM17321

Drug: HM17321

Study type

Interventional

Funder types

Industry

Identifiers

NCT07219589

HM-UCN2-101

Details and patient eligibility

About

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single ascending doses in healthy adult participants.

Full 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 adult participants.

The study will enroll approximately 40 healthy adults with a body mass index (BMI) of ≥20 kg/m² and ≤27 kg/m². Participants will be assigned to 1 of 5 cohorts, with each cohort consisting of 8 participants (6 receiving HM17321 and 2 receiving placebo). The total sample size may be adjusted if additional dose cohorts are added and/or existing cohorts are expanded. Participants who discontinue for reasons other than safety may be replaced at the discretion of the Sponsor and Investigator.

All study drugs will be administered by subcutaneous (SC) injection into the abdominal wall.

The study will include a 28-day screening period, a 5-day inpatient stay during which a single SC dose of HM17321 or placebo will be administered, and an outpatient/follow-up period through Day 29. The study duration for each participant will be approximately 8 weeks from screening to the last follow-up visit.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.