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A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects | Clinical Trials | Clareo Health

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A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects

A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2302 vs. Tezspire ® in Healthy Subjects

NCT07327697•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2302 versus Tezspire®（Tezepelumab） in healthy subjects after a single dose.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.
+8 more criteria

Key Dates

Start Date

December 22, 2025

Primary Completion Date

July 1, 2026

Completion Date

September 1, 2026

Last Updated

January 8, 2026

Enrollment

178

ESTIMATED participants

Conditions

Healthy Participants

Interventions

QL2302

DRUG

Tezspire

DRUG

Contacts

YU CAO, PPD

CONTACT

18661809090 caoyu1767@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

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