Trials / Active Not Recruiting
Active Not RecruitingNCT07479576
A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects
A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 190 (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 QL2106 versus Tremfye®（Guselkumab） in healthy subjects after a single dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL2106 | 100mg/1 ml; single dose； subcutaneous injection |
| DRUG | Tremfye® | 100mg/1 ml; single dose； subcutaneous injection |
Timeline
- Start date
- 2025-11-10
- Primary completion
- 2026-04-12
- Completion
- 2026-08-30
- First posted
- 2026-03-18
- Last updated
- 2026-03-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07479576. Inclusion in this directory is not an endorsement.