Clinical Trial

To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants

Not Yet Recruiting Phase 1
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Summary
This Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and cytokine profiles of LYNC-101 for Injection in healthy adult participants. The study consists of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study. In Part 1, participants will receive a single intravenous infusion of LYNC-101 for Injection or placebo across sequential ascending dose cohorts. In Part 2, participants will receive intravenous infusions of LYNC-101 for Injection or placebo once every 3 weeks for a total of 3 doses across sequential ascending dose cohorts.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-26.
Trial Details
NCT Number NCT07505030
Lead Sponsor LyncBio Therapeutics Co., Ltd.
Conditions UC - Ulcerative Colitis
Enrollment 50 participants
Start Date 2026-05-25
Primary Completion 2027-03-19 (estimated)
Study Completion 2027-04-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-17