NCT07488065

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	SKB575 Injection/SKB575 Placebo	Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2026-03-23
• Last updated: 2026-04-03

Locations

2 sites across 1 country: China