drugset / Trial / NCT06614907

A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®

NCT06614907

Phase 1 Completed 198 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

It is a randomized, double-blinded, parallel, single-dose, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects. A total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml QL2108 injection or Dupixent®.

Timeline

Start
2024-08-31
Primary completion
2024-11-15
Completion
2024-12-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dupilumab Monoclonal antibody 300 mg Subcutaneous
Subject QL2108 Unknown 300 mg Subcutaneous

Indications