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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Hanmi Pharmaceutical Company Limited
Study ID
NCT07219589
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 6, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HM17321
  • Placebo Comparator: Placebo

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321 [ Time Frame: Up to Day 29 (Part A); Up to Day 113 (Part B) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medpace Clinical Pharmacology UnitCincinnatiOhio45227
Leela Vrishabhendra (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Medpace Clinical Pharmacology Unit· Cincinnati, OH

Related Studies