NCT07219589

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Obesity
• Obese

Interventions

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

Timeline

• Start date: 2025-11-06
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-10-22
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study