A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants

NCT07219589 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HM-UCN2-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Obese

Keywords

Obese; Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321

  Number, type, and severity of treatment-emergent adverse events, including changes in vital signs, electrocardiograms, clinical laboratory tests, and immunogenicity assessments following administration of HM17321 or placebo

  Up to Day 29 (Part A); Up to Day 113 (Part B)

Secondary Outcomes (3)

• Peak Plasma Concentration (Cmax) of HM17321

  Up to Day 29 (Part A); Up to Day 113 (Part B)

• Time to Maximum Plasma Concentration (Tmax) of HM17321

  Up to Day 29 (Part A); Up to Day 113 (Part B)

• Area Under Plasma Concentration-Time Curve (AUC) of HM17321

  Up to Day 29 (Part A); Up to Day 113 (Part B)

Other Outcomes (1)

• Change from Baseline in Body Weight

  Up to Day 29 (Part A); Up to Day 113 (Part B)

Study Arms (2)

HM17321

EXPERIMENTAL

Drug: HM17321

Placebo

PLACEBO COMPARATOR

Drug: Placebo of HM17321

Interventions

HM17321 DRUG

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.

HM17321

Placebo of HM17321 DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jimin Han

CONTACT

+82-2-410-9838; jimin.han@hanmi.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be conducted in a double-blind manner. Participants, investigators, and outcome assessors will remain blinded to treatment assignments. Only designated unblinded personnel (e.g., pharmacist or site staff responsible for drug preparation) will have access to treatment allocation information, and they will not be involved in any other study assessments.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in each cohort will be randomly assigned to receive either HM17321 or placebo. Dose levels will be escalated sequentially in separate cohorts after review of safety data.

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 22, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)