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Not Yet RecruitingNCT07327697

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

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
178 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGQL2302210mg/1.91mL; single dose; subcutaneous injection
DRUGTezspire210mg/1.91mL; single dose; subcutaneous injection

Timeline

Start date
2025-12-22
Primary completion
2026-07-01
Completion
2026-09-01
First posted
2026-01-08
Last updated
2026-01-08

Source: ClinicalTrials.gov record NCT07327697. Inclusion in this directory is not an endorsement.

A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects (NCT07327697) · Clinical Trials Directory