A Phase 1 Study of CLYM116 in Normal Healthy Volunteers

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.

Key facts

Study ID

NCT07248865

Run by

Climb Bio, Inc.

People needed

48

Starts

2025-12-02

Expected to finish

2026-09-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• Prior treatment with investigational drugs within 30 days or 5 half-lives
• Previous or current hypogammaglobulinemia
• Current presence of allergic reactions considered clinically significant
• Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis
• Tobacco use (>2 cigarettes/day), alcohol abuse, or drug abuse
• Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)

Where it is running

• Nucleus Network Brisbane — Brisbane, Australia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.