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

NCT07505030 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

  • UC - Ulcerative Colitis

Interventions

DRUG

LYNC-101

SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.

DRUG

LYNC-101 Placebo

LYNC-101 Placebo SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.

Sponsors & Collaborators

  • LyncBio Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Cexiong Fu · LyncBio Therapeutics Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Days
Max Age
60 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-28
Primary Completion
2027-03-19
Completion
2027-04-11

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07505030 on ClinicalTrials.gov