Could a cheaper dupixent be on the horizon? early trial launches
NCT ID NCT07334496
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial will test whether a new injection called GLR1044 works like the approved drug Dupixent in the body. About 198 healthy Chinese men will receive a single dose of either GLR1044 or Dupixent. Researchers will compare how the drugs are absorbed and processed, and monitor for any side effects over two months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GLR1044 injection (a proposed biosimilar to dupilumab)
- What this could lead to
- If successful, this could lead to a more affordable version of Dupixent for treating conditions like asthma and eczema.
- What could go wrong
- This is an early phase 1 study in healthy people, not patients. It only checks if the drug behaves similarly, not if it works for any disease. Results may not predict real-world effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Gobroad Hospital
Beijing, Beijing Municipality, China