Actively Recruiting
A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
90
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be able to understand and follow study requirements and voluntarily sign informed consent.
- For Phase Ia healthy participants: Age 18 to 55 years, any gender.
- For Phase Ia healthy participants: Males must weigh at least 50 kg, females at least 45 kg, and BMI between 18.0 and 28.0 kg/m2.
- For Phase Ia healthy participants: No clinically significant abnormalities.
- For Phase Ib atopic dermatitis participants: Age 18 to 70 years, any gender.
- For Phase Ib atopic dermatitis participants: Weight at least 45 kg.
- For Phase Ib participants: Diagnosis of atopic dermatitis for at least 1 year meeting American Dermatology Consensus Criteria.
- At screening and baseline: EASI score at least 16.
- At screening and baseline: Investigator Global Assessment (IGA) score of 3 or higher (moderate to severe).
- At screening and baseline: Body surface area of lesions at least 10%.
- Participants must have used potent or super potent topical corticosteroids, systemic corticosteroids, or topical calcineurin inhibitors for at least 4 weeks prior to screening.
You will not qualify if you...
- History of significant diseases affecting cardiovascular, hematological, liver, kidney, digestive, neurological, respiratory, psychiatric, or metabolic systems.
- History of any cancer, regardless of treatment or recurrence.
- Presence of skin problems at the injection site like scars, inflammation, infection, or bleeding.
- Active infection signs within 4 weeks before randomization.
- History or signs of tuberculosis or abnormal tuberculosis tests.
- Positive tests for Hepatitis B, Hepatitis C, HIV, or syphilis.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Huashan Hospital Affiliated to Fudan University
Shanghai, China, 200040
Actively Recruiting
2
Huashan Hospital Affiliated to Fudan University
Shanghai, China, 200040
Actively Recruiting
Research Team
X
Xin Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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