A Phase 1 Study of CLYM116 in Normal Healthy Volunteers

Climb Bio, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: CLYM116

Study type: Interventional

Funder types: Industry

Identifiers

NCT07248865

CLYM116-NHV-101

Details and patient eligibility

About

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

Full description

CLYM116 is a humanized monoclonal antibody that selectively binds to a proliferation inducing ligand (APRIL). This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of CLYM116 in adult normal healthy volunteers (NHVs). The study will enroll up to 48 subjects, across up to five cohorts.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

CLYM116

Experimental group

Description:

Subcutaneous (SC) injection of CLYM116

Treatment:

Drug: CLYM116

Placebo

Placebo Comparator group

Description:

Subcutaneous (SC) injection of placebo

Treatment:

Drug: Placebo