A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose (SAD) and Multiple-Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection(s) of CLYM116 in Normal Healthy Volunteers
Climb Bio, Inc.
48 participants
Dec 2, 2025
INTERVENTIONAL
Conditions
Summary
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- 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)
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Interventions
CLYM116 to be administered by SC injection
Placebo solution to be administered at a matching volume by SC injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07248865