BiosimilarityPhase 1NCT07334496
A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects
A Phase 1 study testing GLR1044 injection and Dupilumab Injection in people with Biosimilarity, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects. It is planned to enroll 198 male subjects in this study. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Biosimilarity
- What is being tested?
- GLR1044 injection and Dupilumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to 17 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Voluntarily sign the informed consent form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- 2. Male subjects aged 18 to 55 years (both inclusive) at the time of signing informed consent forms.
- 3. Subjects must agree to use reliable contraception for themselves and their partners during the study and within 6 months after the end of the study (the contraception used should comply with local regulations on the use of contraceptive methods for subjects participating in clinical studies), and not donate sperm for assisted reproductive purposes.
- 4. The body mass index (BMI) at screening is 19-26 kg/m2 (both exclusive), and the weight is 55-85 kg (both exclusive).
- 5. The results of medical history review, physical examinations, laboratory tests, imaging examinations and ECG at screening/visit 2 (V2) are judged by the investigator to be normal or abnormal but not clinically significant.
- No personal history of tuberculosis, no possible previous history of tuberculosis exposure, and no previous and/or current immunomodulatory treatment.
- 6.No personal history of tuberculosis, no possible previous history of tuberculosis exposure, and no previous and/or current immunomodulatory treatment.
Who cannot join
- 1.History of drug abuse within 1 year prior to screening, or positive predose drug abuse screening result at Visit 2 (V2); or history of alcohol abuse within 6 months prior to screening, or positive predose alcohol breath test result at V2.
- 2. Subjects who smoked > 5 cigarettes/day within 3 months prior to screening or who cannot stop using any tobacco products during the study.
- 3. The subject and/or first-degree relatives have a history of venous thromboembolic events or idiopathic venous thromboembolic events before screening.
- 4. Presence of sunburn, scar tissue, tattoos, open ulcers or branding at screening that the investigator believes will interfere with the interpretation of adverse skin reactions.
- 5. Eye or oral infections at screening, including but not limited to conjunctivitis, blepharitis and oral herpes.
- 6. The following medical history with a clear diagnosis in the past or at screening: Subjects with cardiovascular disorders, hematological diseases, respiratory disorders, digestive system diseases, abnormal hepatic function, abnormal renal function, endocrine and metabolic disorders (except for overweight), nervous system disorders or psychiatric disorders, skin and subcutaneous tissue disorders, musculoskeletal system disorders, and immune system disorders, who in the opinion of the investigator should be excluded from the study due to the above-mentioned diseases, or other diseases that may interfere with the interpretation of study results.
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- 7. The estimated glomerular filtration rate at screening is < 90 mL/min/1.73m2 as calculated using the CKD-EPI equation.
- 8. Any malignant tumor suspected or diagnosed prior to screening. 9. Subjects with blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or subjects with bone marrow donation.
- 10. Subjects who have undergone major surgery (including but not limited to surgery requiring general anesthesia) or organ transplantation within 3 months prior to screening, or are still in a state of illness, trauma or incomplete recovery from surgery at the time of screening (e.g., significant impairment in daily living or working capacity compared to pre-illness/injury/surgery status), or plan to undergo surgery during the study or within two months after the end of the study.
- 11.Subjects with allergic constitution, or a history of allergic diseases such as bronchial asthma, urticaria, and eczema.
- 12. Known or suspected intolerance or hypersensitivity to any biological drug and its excipients, or known allergy or clinically significant reaction to murine-derived, chimeric, or humanized proteins in monoclonal antibodies or antibody fragments.
- 13. Subjects who tested positive for human immunodeficiency virus (HIV) antigen antibody, treponema pallidum antibody, hepatitis B surface antigen (HBsAg) quantitative assay, hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening.
- 14.Use of Dupilumab Injection and other cytokine (including but not limited to tumor necrosis factor, interleukin, etc.) targeted agents before screening, or use of other drugs that may affect the judgment of this study result within 3 months before screening (including but not limited to Janus kinase (JAK) inhibitor, phosphodiesterase-4 inhibitor, Fc receptor antagonists (Rozanolixizumab, Efgartigimod, etc.), any biological drugs and preparations, etc.); or have used any biological agent containing immunoglobulins within 1 year before screening.
- 15.Subjects who have participated in any clinical trial of an unmarketed drug or vaccine and received medication within 3 months before screening or within 5 half-lives of the previous investigational medicinal product (whichever is longer), or subjects who plan to be vaccinated during the study period or within 2 months after the end of the study.
- 16. Subjects who have used prescription and over-the-counter (OTC) drugs, herbal medicines, traditional Chinese medicines, and Chinese patent medicines without the approval of the investigator within 14 days before administration at Visit 2 (V2).
- 17. Those who are investigators or employees of the study site, or family members of the employees or investigators.
- 18. The investigator believes that there is any condition that may cause the subject to be unable to complete this study or bring obvious risks to the subject, or other investigators believe that the subject has any condition that makes him/her unsuitable for participating in this study, or the subject may not be able to complete this clinical trial for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Gobroad Hospital
Beijing, Beijing Municipality
xiaohua Tian, 010-50847588+682, bjgbll@gobroadhealthcare.com
About this study
Official title: A Randomized, Double-blind, Single-dose, Parallel Comparison Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Chinese Adult Male Subjects
This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects.
It is planned to enroll 198 male subjects in this study. Eligible subjects will be randomized into 2 dosing groups at 1:1 (GLR1044 group or Dupilumab group), i.e., 99 subjects in each group. Each subject is administered once by subcutaneous injection in the abdomen, during which the subject is required to be hospitalized for 4 days. The safety follow-up will last until D57.
- Conditions
- Biosimilarity
- Being tested
- GLR1044 injection, Dupilumab Injection
- Keywords
- Biosimilarity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLR1044 injectionDrug
GLR1044 injection 300mg/2.0mL; subcutaneous injection; single dose
Dupilumab InjectionDrug
Dupilumab Injection 300mg/2.0mL; subcutaneous injection; single dose
| Study group | Role | What they receive |
|---|---|---|
| GLR1044 injection | Experimental | Not described Receives: Drug: GLR1044 injection |
| Dupilumab Injection | Active comparator | Not described Receives: Drug: Dupilumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic indicators:Cmax
Measured: Day 1-Day 57
Pharmacokinetic indicators:AUC0-∞.
Measured: Day 1-Day 57
Secondary outcomes (12)
Pharmacokinetic indicators: AUC0-t
Measured: Day 1-Day 57
Pharmacokinetic indicators: CL
Measured: Day 1-Day 57
Pharmacokinetic indicators: λz
Measured: Day 1-Day 57
Pharmacokinetic indicators: Tmax
Measured: Day 1-Day 57
Pharmacokinetic indicators: t1/2
Measured: Day 1-Day 57
Pharmacokinetic indicators: Vz
Measured: Day 1-Day 57
Pharmacokinetic indicators: MRT
Measured: Day 1-Day 57
Pharmacokinetic indicators: AUC0-t/AUC0-∞ ratio.
Measured: Day 1-Day 57
Safety: Number of treatment-emergent adverse events (TEAEs)
Measured: Day 1-Day 57
Safety: Number of treatment-emergent serious adverse events (TESAEs).
Measured: Day 1-Day 57
Immunogenicity: Anti-drug antibody (ADA)
Measured: Day 1-Day 57
Immunogenicity: neutralizing antibody (NAb)
Measured: Day 1-Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start9 Mar 2026 (estimated)
- Primary completion17 Jul 2026 (estimated)
- Study completion17 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiosimilarityStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334496
- Sponsor's protocol ID
- GLR1044-AD-101
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Parallel Comparison Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Chinese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT07334496
- Acronym / sponsor ID
- GLR1044-AD-101
- Conditions
- Biosimilarity
- Keywords
- Biosimilarity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 17 Jul 2026 (estimated)
- Study completion
- 17 Jul 2026 (estimated)
- First posted
- 12 Jan 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 is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects.
It is planned to enroll 198 male subjects in this study. Eligible subjects will be randomized into 2 dosing groups at 1:1 (GLR1044 group or Dupilumab group), i.e., 99 subjects in each group. Each subject is administered once by subcutaneous injection in the abdomen, during which the subject is required to be hospitalized for 4 days. The safety follow-up will last until D57.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLR1044 injection | Experimental | Drug: GLR1044 injection |
| Dupilumab Injection | Active comparator | Drug: Dupilumab Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1.Voluntarily sign the informed consent form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- 2. Male subjects aged 18 to 55 years (both inclusive) at the time of signing informed consent forms.
- 3. Subjects must agree to use reliable contraception for themselves and their partners during the study and within 6 months after the end of the study (the contraception used should comply with local regulations on the use of contraceptive methods for subjects participating in clinical studies), and not donate sperm for assisted reproductive purposes.
- 4. The body mass index (BMI) at screening is 19-26 kg/m2 (both exclusive), and the weight is 55-85 kg (both exclusive).
- 5. The results of medical history review, physical examinations, laboratory tests, imaging examinations and ECG at screening/visit 2 (V2) are judged by the investigator to be normal or abnormal but not clinically significant.
Key exclusion criteria (17 listed)
- 1.History of drug abuse within 1 year prior to screening, or positive predose drug abuse screening result at Visit 2 (V2); or history of alcohol abuse within 6 months prior to screening, or positive predose alcohol breath test result at V2.
- 2. Subjects who smoked > 5 cigarettes/day within 3 months prior to screening or who cannot stop using any tobacco products during the study.
- 3. The subject and/or first-degree relatives have a history of venous thromboembolic events or idiopathic venous thromboembolic events before screening.
- 4. Presence of sunburn, scar tissue, tattoos, open ulcers or branding at screening that the investigator believes will interfere with the interpretation of adverse skin reactions.
- 5. Eye or oral infections at screening, including but not limited to conjunctivitis, blepharitis and oral herpes.
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 |
|---|---|---|
| GLR1044 injectionGLR1044 injection 300mg/2.0mL; subcutaneous injection; single dose | Drug | GLR1044 injection |
| Dupilumab InjectionDupilumab Injection 300mg/2.0mL; subcutaneous injection; single dose | Drug | Dupilumab Injection |
Primary outcome
Pharmacokinetic indicators:Cmax
Time frame: Day 1-Day 57
Pharmacokinetic indicators:AUC0-∞.
Time frame: Day 1-Day 57
12 secondary outcomes
Pharmacokinetic indicators: AUC0-t
Time frame: Day 1-Day 57
Pharmacokinetic indicators: CL
Time frame: Day 1-Day 57
Pharmacokinetic indicators: λz
Time frame: Day 1-Day 57
Pharmacokinetic indicators: Tmax
Time frame: Day 1-Day 57
Pharmacokinetic indicators: t1/2
Time frame: Day 1-Day 57
Pharmacokinetic indicators: Vz
Time frame: Day 1-Day 57
Pharmacokinetic indicators: MRT
Time frame: Day 1-Day 57
Pharmacokinetic indicators: AUC0-t/AUC0-∞ ratio.
Time frame: Day 1-Day 57
Safety: Number of treatment-emergent adverse events (TEAEs)
Time frame: Day 1-Day 57
Safety: Number of treatment-emergent serious adverse events (TESAEs).
Time frame: Day 1-Day 57
Immunogenicity: Anti-drug antibody (ADA)
Time frame: Day 1-Day 57
Immunogenicity: neutralizing antibody (NAb)
Time frame: Day 1-Day 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 12 Jan 2026.
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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.
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 GLR1044 injection and Dupilumab Injection in people with Biosimilarity, run by Gan & Lee Pharmaceuticals. 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 7 inclusion and 17 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: opening soon, as of the sponsor's last update on 12 Jan 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?
Contact jianpeng su (+8615829644383, jianpeng.su@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic indicators:Cmax (time frame: Day 1-Day 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 12 Jan 2026.