drugset / Trial / NCT07103369
A Phase I Clinical Study to Evaluate SM17 in Chinese Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial is a phase 1, randomized, double-blind, placebo-controlled trial conducted in Chinese Healthy Volunteers and Patients with moderate-to-severe Atopic Dermatitis It aims to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of single and multiple doses of SM17 injection in healthy subjects . It also aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity as well as preliminary efficacy in AD patients.
Timeline
- Start
- 2023-11-21
- Primary completion
- 2025-03-24
- Completion
- 2025-03-31
Outcome
Met primary endpoint
release “This Phase1b study, which evaluated two doses level of SM17 (200mg and 600mg, respectively), met its primary endpoints manifested as the safety profiles” sinomab.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SM17 | Monoclonal antibody | 70 mg | Intravenous |
| Subject | SM17 | Monoclonal antibody | 200 mg | Intravenous |
| Subject | SM17 | Monoclonal antibody | 600 mg | Intravenous |