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NOT YET RECRUITING
NCT07801612
PHASE1

A Phase I Study of HXN5003 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis

Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd

View on ClinicalTrials.gov

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

DRUG

HXN5003

Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of HXN5003.

DRUG

Placebo

Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of placebo.

DRUG

HXN5003

AD participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN5003.

DRUG

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