Actively Recruiting
Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous CLYM116 in Healthy Volunteers
Led by Climb Bio, Inc. · Updated on 2026-02-20
48
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CLYM116, a humanized monoclonal antibody that targets a proliferation inducing ligand (APRIL), in healthy adult volunteers. This Phase 1, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CLYM116. The study plans to enroll up to 48 participants across up to five groups. Participants will receive either subcutaneous injections of CLYM116 or a matching placebo. The study includes both single-ascending-dose and multiple-ascending-dose phases to understand how the drug behaves in the body and its effects over time. Treatments are administered under controlled conditions at a single study center. During the study, volunteers will undergo extensive monitoring including physical exams, ECGs, and laboratory tests. Researchers will track adverse events, injection site reactions, drug concentrations in plasma, immunoglobulin levels, and the presence of anti-drug antibodies. These assessments will occur from screening through to approximately 85 days after dosing, with follow-up visits to ensure safety and collect data on the drug's effects.
CONDITIONS
Brief Title
A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 60 years
- 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 lab results or abnormalities not clinically significant
- Able and willing to follow 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 avoid sperm donation for 4 months after dosing
- Completed COVID-19 vaccination per local guidelines and influenza vaccination within the past 12 months
You will not qualify if you...
- Use of investigational drugs within 30 days or 5 half-lives before the study
- History or current diagnosis of hypogammaglobulinemia
- Clinically significant allergic reactions currently present
- Positive tests for HIV, hepatitis B or C, syphilis, or tuberculosis
- Tobacco use exceeding 2 cigarettes per day, alcohol abuse, or drug abuse
- Receipt of live vaccines within 21 days or any non-live vaccines within 14 days before the study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 85 days
Participants receive subcutaneous injections of either CLYM116 or placebo and are monitored for safety, tolerability, and pharmacokinetic responses.
Multiple visits including baseline, Day 1, Day 4, Day 8, Day 14, Day 15, Day 17, Day 18, Day 22, Day 29, Day 43, Day 71, and Day 85
Duration - Up to final follow-up visit after Day 85
Participants continue to be monitored for safety, immunogenicity, and pharmacodynamics after treatment completion.
Follow-up visit(s) after Day 85
Trial Site Locations
Total: 1 location
1
Nucleus Network Brisbane
Brisbane, Australia, 4006
Actively Recruiting
Research Team
C
Climb Bio Study Director
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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