NCT06173011

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

A Randomized, Double-blind, Single-dose, Parallel Three-group Study to Compare the Pharmacokinetics and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Male Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a phase I,single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single injections of QL2107 or Keytruda® （China/US） in healthy volunteers. The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2107 or Keytruda® （China/US） in healthy volunteers. Subjects would receive a single 100mg（4ml） of QL2107or Keytruda® （China/US）injection.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	QL2107	intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
DRUG	Keytruda®(china)	intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
DRUG	Keytruda®(US)	intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-12-15
• Last updated: 2024-01-23

Locations

1 site across 1 country: China