Comparative Study of QL1209 and Perjeta® in Healthy Male Participants

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.

Timeline

Start

2026-10

Primary completion

2027-04

Completion

2027-09

Drugs

Indications