Cheaper asthma drug on the horizon? new biosimilar QL2302 enters human testing
NCT ID NCT07327697
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 1 trial will compare a single dose of QL2302, a proposed biosimilar of the asthma drug Tezspire, against the original drug in 178 healthy adults aged 18 to 45. The study is double-blinded and randomized, meaning neither participants nor researchers know who gets which treatment. The main goal is to see if the two drugs behave similarly in the body and have comparable safety and immune responses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QL2302 (a proposed biosimilar of tezepelumab)
- What this could lead to
- If successful, this could support the development of a more affordable version of Tezspire for treating severe asthma.
- What could go wrong
- This is an early Phase 1 study in healthy people, not patients. It only tests a single dose, so it cannot show whether the drug works for any disease. Side effects or immune reactions may still occur.
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 178 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 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 45 years
- Sex
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Anyone
- 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. Healthy subjects aged from 18 to 45 years (including the boundary value), male and female. 2. Body weight 50.0-85.0 kg (including boundary value), and BMI 19.0-26.0 kg/m2 (including boundary value). 3. Normal results or abnormal results with no clinical significance of disease history/vital signs/laboratory examination/ECG according to the PI's judgment. 4. The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period, and voluntarily adopts effective contraceptive measures. 5. Sign the informed consent before participating the study, and fully understand the content, process and possible risks. Exclusion Criteria: 1. History of allergic reactions or hypersensitivity to Tezepelumab or excipients, or other biologics. 2. Donated at least 400 mL within 3 months prior to screening, or at least 200 mL within 4 weeks prior to the screening visit, or plan to donate blood during the study. 3. Smoked more than 5 cigarettes on average per day within 3 months prior to the screening visit. 4. Diagnosed as alcoholic, or subjects who consumed more than 14 units of alcohol per week within 6 months before the screening visit, or with positive alcohol test result on Day-1. 5. Drug abusers within 1 year prior to the screening visit, or subjects with positive urine drug test result during the screening period or on Day-1. 6. History of hospitalization due to infection or receiving anti-infection therapy through intravenous within 8 weeks prior to the screening visit, or had infection within 2 weeks prior to the screening visit. 7. Diagnosed a helminth parasitic infection within 6 months prior to the screening visit that has not been treated or has not responded to standard of care therapy. 8. History of active TB infection or a positive TB test result during screening period. 9. History of malignancy (except for NMSC treated with apparent success ≥5 years prior to screening). 10. Diagnosed with disease with abnormal clinical manifestations that should be excluded as judged by the PI. 11. History of treated by Tezepelumab or other TSLP-targeted biologics. 12. Have used prescription, OTC, herbal medicine, or health supplement within 2 weeks prior to randomization. 13. Vaccination with a live vaccine within 4 weeks or a attenuated vaccine within 2 weeks prior to randomization. 14. Have used biologics within 3 months prior to randomization, or within 5 half-life period before randomization. (whichever is longer) 15. Receiving treatment with any investigational product within 3 month prior to randomization or in 5 half-life period (whichever is longer), or treatment with any investigational equipment within 3 month prior to randomization. 16. Positive HbsAg, or HCV-Ab, or TPAb, or HIV antibody tests. 17. Female is pregnant or breastfeeding, or female who have not taken effective contraceptive measures within 14 days prior to randomization, or female with positive blood pregnant test. 18. Other conditions that considered inappropriate for participating the study, as per the investigator.
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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 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.
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