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

NCT07327697 | Not Yet Recruiting Phase 1

• 1 other identifier: QL2302-101
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics Endpoint

  Peak plasma concentration (Cmax)

  Day 1-Day 134

• Pharmacokinetics Endpoint

  Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞)

  Day 1-Day 134

Study Arms (2)

QL2302

EXPERIMENTAL

Drug: QL2302

Tezspire®

ACTIVE COMPARATOR

Drug: Tezspire

Interventions

QL2302 DRUG

210mg/1.91mL; single dose; subcutaneous injection

QL2302

Tezspire DRUG

210mg/1.91mL; single dose; subcutaneous injection

Tezspire®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects aged from 18 to 45 years (including the boundary value), male and female.
• Body weight 50.0-85.0 kg (including boundary value), and BMI 19.0-26.0 kg/m2 (including boundary value).
• Normal results or abnormal results with no clinical significance of disease history/vital signs/laboratory examination/ECG according to the PI's judgment.
• The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period, and voluntarily adopts effective contraceptive measures.
• Sign the informed consent before participating the study, and fully understand the content, process and possible risks.

You may not qualify if:

• History of allergic reactions or hypersensitivity to Tezepelumab or excipients, or other biologics.
• 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.
• Smoked more than 5 cigarettes on average per day within 3 months prior to the screening visit.
• 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.
• 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.
• 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.
• 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.
• History of active TB infection or a positive TB test result during screening period.
• History of malignancy (except for NMSC treated with apparent success ≥5 years prior to screening).
• Diagnosed with disease with abnormal clinical manifestations that should be excluded as judged by the PI.
• History of treated by Tezepelumab or other TSLP-targeted biologics.
• Have used prescription, OTC, herbal medicine, or health supplement within 2 weeks prior to randomization.
• Vaccination with a live vaccine within 4 weeks or a attenuated vaccine within 2 weeks prior to randomization.
• Have used biologics within 3 months prior to randomization, or within 5 half-life period before randomization. (whichever is longer)
• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

tezepelumab

Central Study Contacts

YU CAO, PPD

CONTACT

18661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 8, 2026
• Study Start: December 22, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12