CLYM116 in healthy adults

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

Researchers will test a new antibody called CLYM116 in healthy adults to check safety, how the body processes it, and its immune effects.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Climb Bio, Inc. (industry)
• Locations: 1 site (Brisbane)
• Trial ID: NCT07248865 on ClinicalTrials.gov

What this trial studies

CLYM116 is a humanized monoclonal antibody that selectively binds APRIL, a protein involved in B-cell activity. This is a first-in-human, randomized, double-blind, placebo-controlled, single-center Phase 1 study enrolling up to 48 healthy volunteers across up to five dosing cohorts. The study will collect safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity data following administration of CLYM116 or placebo. Participants will undergo screening, planned dosing and detailed clinical and laboratory monitoring with scheduled follow-up visits.

Who should consider this trial

Good fit: Healthy adults aged 18–60 with BMI 18–32 kg/m² and weight 45–110 kg, with normal clinical exams and labs, who agree to required contraception and study procedures are ideal candidates.

Not a fit: People with active infections, positive HIV/hepatitis/tuberculosis tests, prior hypogammaglobulinemia, recent investigational drug use, significant medical conditions, pregnancy or breastfeeding, or inability to comply with contraception or visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If CLYM116 is safe and shows the expected biological activity, it could support development of new treatments that target APRIL-related immune disorders, including some autoimmune diseases and B-cell malignancies.

How similar studies have performed: Other agents targeting the APRIL/BAFF pathway have demonstrated biological activity in early trials but clinical benefits have been mixed and some programs reported safety concerns.

Eligibility criteria

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 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 this trial is running

Brisbane

• Nucleus Network Brisbane — Brisbane, Australia (RECRUITING)

Study contacts

• Study coordinator: Climb Bio Study Director

Conditions: Healthy Volunteers, CLYM116, APRIL, monoclonal antibody, healthy volunteers, Phase 1, IgA nephropathy, MIL116