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A Phase I Study of HXN5003 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd
Summary
This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN5003 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD). The study consists of two parts: Part A (single ascending dose in healthy participants) and Part B (multiple ascending dose in AD patients). The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of HXN5003.
Official title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of HXN5003 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2026-09
Completion Date
2028-01
Last Updated
2026-09-03
Healthy Volunteers
Yes
Interventions
HXN5003
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of HXN5003.
Placebo
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of placebo.
HXN5003
AD participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN5003.
Placebo
AD Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Locations (1)
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China