A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
| Condition(s) | Healthy Volunteers |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers. |
| Who can participate | Inclusion Criteria: * Healthy adult males and females aged 18-60 years, inclusive * Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg * Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant) * Willing and able to comply with study procedures and provide informed consent * Women of childbearing potential must use highly effective contraception and have negative pregnancy tests * Men must use contraception and refrain from sperm donation for 4 months post-dose * Completion of COVID-19 vaccination according to local guidelines, as well as influenza vaccination (within 12 months) Exclusion Criteria: * Prior treatment with investigational drugs within 30 days or 5 half-lives * Previous or cu |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Climb Bio, Inc. |
| Locations | Brisbane, Australia |
| Start date | 2025-12-02 |
| NCT ID | NCT07248865 |
| Official listing | https://clinicaltrials.gov/study/NCT07248865 |