drugset / Trial / NCT07103369

A Phase I Clinical Study to Evaluate SM17 in Chinese Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis

NCT07103369 ↗

Phase 1 Completed 64 enrolled SinoMab BioScience Ltd
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

EvaluationDrugModalityDoseRoute
Subject SM17 Monoclonal antibody 70 mg Intravenous
Subject SM17 Monoclonal antibody 200 mg Intravenous
Subject SM17 Monoclonal antibody 600 mg Intravenous

Indications