A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chin… (NCT07502534) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
China180 participantsStarted 2026-04-24
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 range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak drug concentration (Cmax)
Timeframe: Days 1-57
2
Area under the plasma concentration-time curve (AUC0-∞).
. 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;