drugset / Trial / NCT06173011

A Study Comparing Pharmacokinetic and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Adults

NCT06173011

Phase 1 Unknown 168 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2107 with Keytruda® marketed in China and the United States in healthy male volunteers. Participants will receive a single injection of QL2107/ Keytruda® (China)/Keytruda® (US).Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the three groups.

Timeline

Start
2023-12-12
Primary completion
2024-07
Completion
2024-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pembrolizumab Monoclonal antibody 100 mg Intravenous
Subject QL2107 Unknown 100 mg Intravenous

Indications