RecruitingPhase 1NCT07488065

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

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

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

90 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Atopic Dermatitis

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SKB575 Injection/SKB575 Placebo for people with atopic dermatitis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB575 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

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NCT07488065

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