A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM17321 in Healthy and Obese Participants
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 28 days, 45 days
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Part A will include a screening period of up to 28 days, a 5-day inpatient stay with single SC dosing, and an outpatient follow-up period through Day 29, with an overall study duration of approximately 8 weeks per participant."
- "Part B will include a screening period of up to 45 days, a 12-week treatment period with once-weekly SC dosing, and a 4-week follow-up period through Day 113, with an overall study duration of approximately 22 weeks per participant."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 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. * Additional Exclusion Criteria for Part B * HbA1c ≥6.5% or a history of diabetes mellitus (type 1 or type 2). * Obesity induced by other endocrine disorders (e.g., Cushing syndrome). * Use of weight control treatments (e.g., GLP-1 receptor agonists or other anti-obesity medications) and antihypertensive medications within 3 months prior to screening. * Use of any lipid-lowering medications, unless on a stable dose for at least 3 months prior to screening.
Study sites (1)
OH
- Medpace Clinical Pharmacology Unit · Cincinnati, OH 45227Leela Vrishabhendra · Principal investigatorMore trials in Cincinnati