A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chin… (NCT07502534) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
China180 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Peak drug concentration (Cmax)
Timeframe: Days 1-57
2
Area under the plasma concentration-time curve (AUC0-∞).
. 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;