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

ConditionsObesity Obese

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorHanmi Pharmaceutical Company Limited

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: HM17321Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame