A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers

NCT07502534 | Active Not Recruiting Phase 1

• 1 other identifier: CIBI3027A101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers. Healthy volunteers will be randomly assigned in a 1:1 ratio to receive either IBI3027 or DUPIXENT?. The dosage for both groups is 300 mg. The entire study includes a 28-day screening period and a 56-day observation period (including 3 days of hospitalization). Randomization is stratified by body weight at baseline (D1) ≤ 70 kg vs. \> 70 kg.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Peak drug concentration (Cmax)

  Days 1-57

• Area under the plasma concentration-time curve (AUC0-∞).

  Days 1-57

Secondary Outcomes (8)

• Area under the plasma concentration-time curve (AUClast)

  Days 1-57

• volume of distribution (V/F)

  Days 1-57

• clearance rate (CL/F)

  Days 1-57

• Anti-drug antibodies (ADA)

  Days 1-57

• Neutralizing antibodies (NAb)

  Days 1-57

Study Arms (2)

IBI3027 treatment group

EXPERIMENTAL

The participants in this group will receive a 300 mg subcutaneous injection of IBI3027 on the first day.

Drug: IBI3027

DUPIXENT® (dupilumab) treatment group

ACTIVE COMPARATOR

The participants in this group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day.

Drug: DUPIXENT® (dupilumab)

Interventions

IBI3027 DRUG

The participants in IBI3027 treatment group will receive a 300 mg subcutaneous injection of IBI3027 on the first day.

IBI3027 treatment group

DUPIXENT® (dupilumab) DRUG

The participants in DUPIXENT® (dupilumab) treatment group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day.

DUPIXENT® (dupilumab) treatment group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Follow the test procedures and voluntarily sign the informed consent form;
• Male individuals aged 18 to 45 years (inclusive of the boundary value);
• Weight between 63 and 75 kg (inclusive of the boundary value);
• Agree to take contraceptive measures from the screening period to 120 days after the administration of the study drug.

You may not qualify if:

• Those with a history of severe, progressive, and uncontrolled diseases in the liver, kidneys, cardiovascular system, nervous/psychiatric system, gastrointestinal tract, respiratory system, urinary system, endocrine system, hematologic system, etc.;
• Individuals with a known history of recurrent or chronic infections, including but not limited to: chronic kidney infections, chronic thoracic infections (e.g., bronchiectasis), sinusitis, recurrent urinary tract infections, or infected open wounds, draining wounds, or skin infections;
• Those with a known history of tuberculosis or clinical manifestations suspected of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.), or those with a positive IGRA test result;
• Participants who had opportunistic infections within 180 days before screening (e.g., herpes zoster, active cytomegalovirus, Pneumocystis carinii, Histoplasma capsulatum, Aspergillus, Mycobacterium tuberculosis, etc.);
• Participants who had an acute infection history within 14 days before screening;
• Those with a known history of immune system diseases (e.g., thymic diseases, systemic lupus erythematosus);
• Those with a history of malignancy;
• Participants with abnormal vital signs and physical examination findings during the screening period, as judged clinically significant by the investigator;
• Participants with abnormal laboratory test results during screening, including blood routine (absolute white blood cells count\< 3.50×10\^9/L, or \> 9.50×10\^9/L, absolute neutrophil count\< 1.8×10\^9/L, platelet count \< 100×10\^9/L, hemoglobin \< 100 g/L), urinalysis, blood biochemistry \[Alanine Transaminase (ALT), Aspartate Amino Transferase (AST), Total Bilirubin (TBIL), Direct Bilirubin (DBIL) \> 1.5×upper limit of normal (ULN), Creatinine (Cr) \> ULN\], coagulation function or thyroid function as judged clinically significant by the investigator;
• Participants with abnormal chest X-ray (posteroanterior and lateral views) during the screening period, as judged clinically significant by the investigator;
• Individuals testing positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, syphilis antibody (either specific or non-specific), hepatitis B surface antigen (HBsAg), or hepatitis B e antigen (HBeAg);
• Those who had received IL-4Rα monoclonal antibody treatment in the past;
• Use of any medication (including traditional Chinese medicine and vitamins) within 14 days prior to screening, or use of any medication less than five half-lives before the administration of study drug, whichever is longer;
• Participants who had participated in other interventional clinical trials within 90 days before screening;
• Participants who had undergone major surgery or been hospitalized for illness within 90 days before screening;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Qingdao University Affiliated Hospital

Qingdao, Shandong, Shandong Province, China

Location

MeSH Terms

Interventions

dupilumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: March 31, 2026
• Study Start: April 24, 2026
• Primary Completion: July 7, 2026
• Study Completion: July 7, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)