GS101 vs Dupixent® for Atopic Dermatitis

A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection

Recruiting Phase 1 Interventional Study
Atopic Dermatitis (AD)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 55
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
294 (estimated)
Sponsor
Jiangsu Genscend Biopharmaceutical Co., Ltd · Industry
Who this trial is looking for

This trial is looking for healthy adult men in China to compare two treatments for atopic dermatitis. Participants will receive either the GS101 injection or Dupixent® and will be monitored for safety and how their bodies respond to the treatments.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a healthy adult male
  • I weigh between 55 and 85 kg
  • My body mass index (BMI) is between 19 and 26
  • I agree to use contraception with my partner
  • I do not plan to donate sperm
  • My health screenings show no significant issues

You may not be able to join if

  • I have a history of certain diseases that could affect the study
  • I have allergies to multiple drugs or foods
  • I have a known allergy to certain monoclonal antibodies
  • I tested positive for any infectious diseases

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. A total of 294 healthy male adult participants, with 98 participants per treatment group across 3 groups.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * No clinically significant abnormalities detected in physical examination, vital signs, chest X-ray (posteroanterior \[PA\] view), 12-lead ECG, or laboratory tests prior to investigational product administration. * Body mass index (BMI) between 19 and 26 kg/m² (inclusive) and b…
Contacts

Sinian Li, Master

+086-15800767550

lisinian@jxingbio.com

CONTACT

Tao Sun, Master

+086-15921575347

suntao@jxingbio.com

CONTACT