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ACTIVE NOT RECRUITING
NCT07479576
PHASE1

A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects

Sponsor: 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 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

Interventions

DRUG

QL2106

100mg/1 ml; single dose; subcutaneous injection

DRUG

Tremfye®

100mg/1 ml; single dose; subcutaneous injection

Locations (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China