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NOT YET RECRUITING
NCT07782476
PHASE1/PHASE2

Study of HXN6005 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/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

DRUG

HXN6005

Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.

DRUG

Placebo

Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.

DRUG

HXN6005

Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.

DRUG

Placebo

Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.

DRUG

HXN6005

Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.

DRUG

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