AzTrials
AzTrials

Healthy ParticipantsPhase 1NCT07791342

A Phase I Study of 9MW4113 Injection Versus Dupixent®

A Phase 1 study testing 9MW4113 injection and Dupilumab in people with Healthy Participants, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

It is a randomized, double-blinded, parallel, single-dose, Phase I comparative study to evaluate the pharmacokinetic, safety, and immunogenicity similarity between 9MW4113 and Dupixent® in healthy Chinese adult participants. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
9MW4113 injection and Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteChina
Study dates
22 Apr 2026to 17 Aug 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • Chinese healthy participants aged 18 to 50 years, inclusive.
  • Body weight between 55 and 85kg, inclusive, body mass index between 19.0 and 28.0kg/m2, inclusive.
  • Normal vital signs, physical examination, clinical laboratory test results, and other ancillary examination findings, or abnormalities considered not clinically significant by the investigator.
  • 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.
  • Participants able to communicate well with the investigator and able to understand and comply with all study requirements.

Who cannot join

  • Participants with a history of specific allergies or with allergic diathesis (e.g., allergy to two or more drugs or foods).
  • Known hypersensitivity to any component of the investigational product or to other similar biological products, especially monoclonal antibodies.
  • Presence of active tuberculosis infection as revealed by chest X-ray at screening.
  • ≥ 5% change (increase or decrease) in body weight at Day -1 (pre-randomization) versus screening.
  • History of chronic or significant diseases involving the cardiovascular, digestive, genitourinary, respiratory, hematologic, endocrine, immune, psychiatric/neurological, or skeletal systems.
  • Prior treatment with a monoclonal antibody targeting the same target, or prior participation in a dupilumab clinical trial.
  • Use of biological products within 3 months or 5 half-lives (whichever is longer) prior to screening.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)

    Wuhan, Hubei, 430023

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Parallel Study to Evaluate the Pharmacokinetic, Safety, and Immunogenicity Similarity Between 9MW4113 and Dupixent® Following a Single Subcutaneous Dose in Healthy Participants

It is a randomized, double-blinded, parallel, single-dose, Phase I comparative study to evaluate the pharmacokinetic, safety, and immunogenicity similarity between 9MW4113 and Dupixent® in healthy Chinese adult participants. A total of 208 healthy participants are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml 9MW4113 injection or Dupixent®.

Being tested
9MW4113 injection, Dupilumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 9MW4113 injectionBiological

    "9MW4113 injection; 300mg/2.0mL; subcutaneous injection.

  • DupilumabBiological

    "Dupixent®; 300mg/2.0mL; subcutaneous injection.

Study groups in NCT07791342
Study groupRoleWhat they receive
9MW4113 injectionExperimental"9MW4113 injection; 300mg/2.0mL; subcutaneous injection. This group includes 104 patients."
Receives: Biological: 9MW4113 injection
Dupixent®Active comparator"Dupixent®; 300mg/2.0mL; subcutaneous injection. This group includes 104 patients."
Receives: Biological: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics Endpoint

    Maximum Concentration (Cmax)

    Measured: 0-9weeks

  2. Pharmacokinetics Endpoint

    Area under the concentration-time curve time 0 to infinity (AUC0-∞)

    Measured: 0-9weeks

Secondary outcomes (11)

  1. Pharmacokinetics Endpoint

    Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)

    Measured: 0-9weeks

  2. Pharmacokinetics Endpoint

    Time of maximum concentration (Tmax)

    Measured: 0-9weeks

  3. Pharmacokinetics Endpoint

    Terminal elimination rate constant (λz)

    Measured: 0-9weeks

  4. Pharmacokinetics Endpoint

    Terminal elimination half-life (t1/2z), t1/2z = ln2/λz

    Measured: 0-9weeks

  5. Pharmacokinetics Endpoint

    Percentage of extrapolated area (AUC_%Extrap), AUC_%Extrap = [(AUC0-∞-AUC0-t)/AUC0-∞]×100%

    Measured: 0-9weeks

  6. Pharmacokinetics Endpoint

    Apparent clearance (CL/F), CL/F=Dose/AUC0-∞

    Measured: 0-9weeks

  7. Pharmacokinetics Endpoint

    Apparent volume of distribution (Vd/F) , Vd/F = (CL/F)/λz

    Measured: 0-9weeks

  8. Safety Assessments

    adverse events, concomitant medications, concomitant non-drug therapies, injection site irritation assessment, laboratory tests (complete blood count, blood biochemistry test, urinalysis and coagulation function) clinical symptoms, vital signs , 12 lead ECGs, physical examination

    Measured: 0-9weeks

  9. Incidence of anti-drug antibodies (ADA)

    Measured: 0-9weeks

  10. Titer of anti-drug antibodies (ADA)

    Measured: 0-9weeks

  11. Incidence of neutralizing antibodies (NAb)

    Measured: 0-9weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start22 Apr 2026
  3. Primary completion27 Jul 2026
  4. Study completion17 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791342
Sponsor's protocol ID
9MW4113-CP101
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 9MW4113 injection and Dupilumab in people with Healthy Participants, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Endpoint (time frame: 0-9weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in