Healthy VolunteersPhase 1NCT07502534
A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
A Phase 1 study testing IBI3027 and DUPIXENT® (dupilumab) in people with Healthy Volunteers, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IBI3027 and DUPIXENT® (dupilumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2026to 7 Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Participants who had lost blood, donated blood or received any blood product infusion ≥ 400 mL within 90 days before screening;
- Participants who had received live vaccines within 180 days before screening, or were expected to receive live vaccines during the study period;
- Participants who had a history of alcohol and/or drug abuse within 1 year before screening, or those with positive drug screening results;
- Participants who had alcohol intake within 72 hours before screening or had a positive alcohol screening result;
- Those suspected or confirmed to have an allergic constitution, or who have had previous allergic reactions to drugs or foods, with a clear history of allergies and/or who are allergic to the test drug or its components;
- Participants who have a fertility plan from the screening period to 120 days after the administration of the investigational drug, or who are unwilling to take the contraceptive measures stipulated in the protocol during the trial;
- Those with disabilities, bedridden, dependent on a wheelchair, or unable to take care of themselves;
- Any other condition deemed by the investigator as rendering the participant unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Qingdao University Affiliated Hospital
Qingdao, Shandong, Shandong Province
About this study
Official title: A Phase I, Randomized, Double-masked, Parallel-group Clinical Trial Evaluating the Bioequivalence and Safety of a Single Subcutaneous Dose of IBI3027 Monoclonal Antibody Injection Versus DUPIXENT® (Dupilumab) in Healthy Adult Chinese Male Volunteers.
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
- Being tested
- IBI3027, DUPIXENT® (dupilumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3027Drug
The participants in IBI3027 treatment group will receive a 300 mg subcutaneous injection of IBI3027 on the first day.
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.
| Study group | Role | What they receive |
|---|---|---|
| IBI3027 treatment group | Experimental | The participants in this group will receive a 300 mg subcutaneous injection of IBI3027 on the first day. Receives: 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. Receives: Drug: DUPIXENT® (dupilumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak drug concentration (Cmax)
Measured: Days 1-57
Area under the plasma concentration-time curve (AUC0-∞).
Measured: Days 1-57
Secondary outcomes (8)
Area under the plasma concentration-time curve (AUClast)
Measured: Days 1-57
volume of distribution (V/F)
Measured: Days 1-57
clearance rate (CL/F)
Measured: Days 1-57
Anti-drug antibodies (ADA)
Measured: Days 1-57
Neutralizing antibodies (NAb)
Measured: Days 1-57
Elimination half-life (t1/2)
Measured: Days 1-57
The number and proportion of serious adverse events related to the experimental drug
Measured: Days 1-57
The number and proportion of treatment-related adverse events during the trial period
Measured: Days 1-57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start24 Apr 2026
- Primary completion7 Jul 2026 (estimated)
- Study completion7 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502534
- Sponsor's protocol ID
- CIBI3027A101
- Status last verified
- May 2026
- First submitted
- 26 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-masked, Parallel-group Clinical Trial Evaluating the Bioequivalence and Safety of a Single Subcutaneous Dose of IBI3027 Monoclonal Antibody Injection Versus DUPIXENT® (Dupilumab) in Healthy Adult Chinese Male Volunteers.
- ClinicalTrials.gov ID
- NCT07502534
- Acronym / sponsor ID
- CIBI3027A101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 7 Jul 2026 (estimated)
- Study completion
- 7 Jul 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI3027 treatment group | Experimental | Drug: IBI3027The participants in this group will receive a 300 mg subcutaneous injection of IBI3027 on the first day. |
| DUPIXENT® (dupilumab) treatment group | Active comparator | Drug: DUPIXENT® (dupilumab)The participants in this group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3027The participants in IBI3027 treatment group will receive a 300 mg subcutaneous injection of IBI3027 on the first day. | Drug | IBI3027 treatment group |
| DUPIXENT® (dupilumab)The participants in DUPIXENT® (dupilumab) treatment group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day. | Drug | DUPIXENT® (dupilumab) treatment group |
Primary outcome
Peak drug concentration (Cmax)
Time frame: Days 1-57
Area under the plasma concentration-time curve (AUC0-∞).
Time frame: Days 1-57
8 secondary outcomes
Area under the plasma concentration-time curve (AUClast)
Time frame: Days 1-57
volume of distribution (V/F)
Time frame: Days 1-57
clearance rate (CL/F)
Time frame: Days 1-57
Anti-drug antibodies (ADA)
Time frame: Days 1-57
Neutralizing antibodies (NAb)
Time frame: Days 1-57
Elimination half-life (t1/2)
Time frame: Days 1-57
The number and proportion of serious adverse events related to the experimental drug
Time frame: Days 1-57
The number and proportion of treatment-related adverse events during the trial period
Time frame: Days 1-57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3027 and DUPIXENT® (dupilumab) in people with Healthy Volunteers, run by Innovent Biologics (Suzhou) 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 4 inclusion and 23 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 15 May 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?
Peak drug concentration (Cmax) (time frame: Days 1-57). 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?
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 15 May 2026.