NCT07791342

Brief 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. 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®.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 11, 2026

Last Update Submit

August 25, 2026

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics Endpoint

    Maximum Concentration (Cmax)

    0-9weeks

  • Pharmacokinetics Endpoint

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

    0-9weeks

Secondary Outcomes (11)

  • Pharmacokinetics Endpoint

    0-9weeks

  • Pharmacokinetics Endpoint

    0-9weeks

  • Pharmacokinetics Endpoint

    0-9weeks

  • Pharmacokinetics Endpoint

    0-9weeks

  • Pharmacokinetics Endpoint

    0-9weeks

  • +6 more secondary outcomes

Study Arms (2)

9MW4113 injection

EXPERIMENTAL

"9MW4113 injection; 300mg/2.0mL; subcutaneous injection. This group includes 104 patients."

Biological: 9MW4113 injection

Dupixent®

ACTIVE COMPARATOR

"Dupixent®; 300mg/2.0mL; subcutaneous injection. This group includes 104 patients."

Biological: Dupilumab

Interventions

9MW4113 injectionBIOLOGICAL

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

9MW4113 injection
DupilumabBIOLOGICAL

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

Dupixent®

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)

Wuhan, Hubei, 430023, China

Location

MeSH Terms

Interventions

dupilumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 27, 2026

Study Start

April 22, 2026

Primary Completion

July 27, 2026

Study Completion

August 17, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)