NCT07248865

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Climb Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CLYM116	CLYM116 to be administered by SC injection
DRUG	Placebo	Placebo solution to be administered at a matching volume by SC injection

Timeline

• Start date: 2025-12-02
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-11-25
• Last updated: 2026-02-20

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study