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

NCT07103369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-08-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SM17 for injection

SM17 monoclonal antibody for intravenous infusion use

OTHER

SM17 placebo for injection

placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein

Sponsors & Collaborators

  • SinoMab BioScience Ltd

    lead INDUSTRY

Principal Investigators

  • Xin-Hua Gao, MD · The First Hospital of China Medical University，Shenyang，Liaoning

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2025-03-24
Completion
2025-03-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103369 on ClinicalTrials.gov