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

NCT06173011 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-01-23

No results posted yet for this study

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.

Conditions

  • Tumor

Interventions

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)

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173011 on ClinicalTrials.gov