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Can a copycat drug match Dupixent's effects?

NCT ID NCT07791342

Knowledge-focused Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This Phase 1 trial compares a new injection called 9MW4113 to the approved drug Dupixent (dupilumab). Researchers give a single dose to 208 healthy Chinese adults aged 18 to 50. They measure how the drug moves through the body, its safety, and whether it triggers an immune response. The goal is to see if 9MW4113 behaves like Dupixent, which could lead to a more affordable treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
9MW4113 injection, a proposed biosimilar to dupilumab (Dupixent)
What this could lead to
If 9MW4113 matches Dupixent, it could become a more affordable alternative for treating conditions like asthma and eczema.
What could go wrong
This is an early-stage trial in healthy people, so it won't show if the drug works for diseases. The biosimilar may not prove to be equivalent, and rare side effects may not appear in this small group.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

208 people

The number who actually took part.

Started

Apr 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1. Participants who fully understand the study objectives, nature, methods, and possible adverse reactions, volunteer to participate, and sign the ICF before any study-related procedures begin. 2. Chinese healthy participants aged 18 to 50 years, inclusive. 3. Body weight between 55 and 85kg, inclusive, body mass index between 19.0 and 28.0kg/m2, inclusive. 4. Normal vital signs, physical examination, clinical laboratory test results, and other ancillary examination findings, or abnormalities considered not clinically significant by the investigator. 5. Female participants who are not planning to become pregnant and who agree to use adequate contraception from 2 weeks prior to screening to 6 months after dosing. 6. Participants able to communicate well with the investigator and able to understand and comply with all study requirements. Exclusion Criteria: 1. Participants with a history of specific allergies or with allergic diathesis (e.g., allergy to two or more drugs or foods). 2. Known hypersensitivity to any component of the investigational product or to other similar biological products, especially monoclonal antibodies. 3. Presence of active tuberculosis infection as revealed by chest X-ray at screening. 4. ≥ 5% change (increase or decrease) in body weight at Day -1 (pre-randomization) versus screening. 5. History of chronic or significant diseases involving the cardiovascular, digestive, genitourinary, respiratory, hematologic, endocrine, immune, psychiatric/neurological, or skeletal systems. 6. Prior treatment with a monoclonal antibody targeting the same target, or prior participation in a dupilumab clinical trial. 7. Use of biological products within 3 months or 5 half-lives (whichever is longer) prior to screening.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy participants

Contacts and locations

Locations

  • Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)

    Wuhan, Hubei, 430023, China

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