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A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®(Guselkumab) in healthy subjects after a single dose.
Official title: A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2025-11-10
Completion Date
2026-08-30
Last Updated
2026-03-18
Healthy Volunteers
Yes
Conditions
Interventions
QL2106
100mg/1 ml; single dose; subcutaneous injection
Tremfye®
100mg/1 ml; single dose; subcutaneous injection
Locations (1)
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China