Hanmi Pharmaceutical Company Limited
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.
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321, a urocortine 2 (UCN2) analog, administered by subcutaneous (SC) injection in healthy and obese participants. The study consists of two parts: Part A (Single Ascending Dose) and Part B (Multiple Ascending Dose), with approximately 90 participants to be enrolled in total. In Part A, approximately 40 healthy participants with a body mass index (BMI) of ≥20 kg/m² and ≤27 kg/m² will be enrolled a…
Inclusion Criteria: * 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. Exclusion Criteria: * History of any bariatri…
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.
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.
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