New biosimilar aims to rival blockbuster eczema drug
NCT ID NCT07411755
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests whether a new drug called GS101 works like the approved eczema treatment Dupixent. Researchers will give a single shot to 294 healthy adults in China and compare how the drug moves through the body, its safety, and immune response. The goal is to see if GS101 could be a similar, possibly cheaper option for managing atopic dermatitis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GS101 injection (a biosimilar of Dupixent)
- What this could lead to
- If successful, this could provide a more affordable alternative to Dupixent for managing eczema symptoms.
- What could go wrong
- This is an early Phase 1 trial in healthy people, not patients. It only checks if the drug is similar, not if it works for eczema. Side effects or differences may still appear.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 294 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 body weight between 55 and 85 kg (inclusive). * Participants and their partner agree to use medically accepted contraceptive methods from the signing of the informed consent form until three months after dosing of the investigational product. In addition, participants have no plans to donate sperm, and their partner has no plans for pregnancy. Exclusion Criteria: * History or presence at screening of neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematologic/lymphatic, endocrine, musculoskeletal, or any other disease judged by the investigator to interfere with study assessments. * History of drug or food allergy (≥2 types) or history of specific allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known hypersensitivity to monoclonal antibodies targeting the same pathway or to investigational product components. * Positive result for any infectious disease screening, including human immunodeficiency virus (HIV) antibody and p24 antigen, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) IgG antibody, or Treponema pallidum (syphilis) antibody.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215004, China
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