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Study of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd
Summary
This is a Phase I/II, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN6005 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD). The study consists of three parts: Part A (single ascending dose in healthy participants), Part B (multiple ascending dose in AD patients), and Part C (multiple-dose efficacy and safety assessment in AD patients). The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HXN6005.
Official title: A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HXN6005 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
67
Start Date
2026-09
Completion Date
2028-01
Last Updated
2026-08-24
Healthy Volunteers
Yes
Interventions
HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
HXN6005
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Placebo
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
Locations (1)
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China