Actively Recruiting
A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
Led by Climb Bio, Inc. · Updated on 2026-02-20
48
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
CONDITIONS
Official Title
A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult males and females aged 18-60 years, inclusive
- Body mass index (BMI) between 18 and 32 kg/m8 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 will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network Brisbane
Brisbane, Australia, 4006
Actively Recruiting
Research Team
C
Climb Bio Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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