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RECRUITING
NCT07488065
PHASE1

A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.

Official title: A Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-03-31

Completion Date

2028-06-30

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

DRUG

SKB575 Injection/SKB575 Placebo

Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Locations (2)

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Huashan Hospital Affiliated to Fudan University

Shanghai, China