Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT07103369
Brief 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.
Detailed Description:
This trial consists of 2 parts:
Part 1 (Ph1a) trial of the study is a dose-ascending study to evaluate the safety, tolerability, pharmacokinetic characteristics of SM17 in Chinese healthy volunteers. Safety and PK profiles of SM17 in Chinese population will be established firstly in this study following single and multiple doses of SM17 injection, and possible differences to those of SM17 in US populations will also be evaluated.
Part2 (ph1b) trial of the study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of SM17 in treating patients with moderate-to-severe atopic dermatitis(AD) following multiple doses of SM17 injections at two doses level of SM17 or placebo. PK/PD profiles, immunogenicity profile of SM17 in AD patients will also be evaluated.
Study:
NCT07103369
Study Brief:
Protocol Section:
NCT07103369