Phase 1 Study of Subcutaneous CLYM116 Injections to Assess Safety and Effects in Healthy Adults Aged 18 to 60

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 drugs effects.

A Phase 1 Study of CLYM116 in Normal Healthy Volunteers