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NOT YET RECRUITING
NCT07861139
PHASE1

Comparative Study of QL1209 and Perjeta® in Healthy Male Participants

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male participants. Participants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on D1, followed by observation until Day 99 postdose for PK, safety and immunogenicity assessments.

Official title: A Randomized, Double-Blind, Single-Dose, Parallel-Controlled Clinical Study to Compare the Pharmacokinetic Similarity Between QL1209 (Perjeta® Biosimilar Candidate) and Perjeta® (Pertuzumab) in Healthy Male Participants

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-10

Completion Date

2027-09

Last Updated

2026-10-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

QL1209

A single intravenous infusion of QL1209 420 mg for 60 min ± 10 min.

DRUG

US-Perjeta®

A single intravenous infusion of US-Perjeta® 420 mg for 60 min ± 10 min.