Comparative Study of QL1209 and Perjeta® in Healthy Male Participants

This is a randomized, double-blind, single-dose, parallel-controlled clinical trial to compare the PK profile of QL1209 and Perjeta® in healthy male participants. It is planned to enroll 80 healthy male participants and randomize them into the test group or reference group at a ratio of 1:1. Participants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on Day 1, followed by observation until Day 99 post-dose for PK, safety and immunogenicity assessments. The study will include a screening period from Day 28 to Day 1. The participants will be admitted to the clinical study site on Day 1 and receive the QL1209 or US-Perjeta® on Day 1. The participants will remain in the in-patient department for observation until the assessment on Day 3 is completed. Participants will return to the clinical study site for out-patient visits till Day 99 or upon early withdrawal. In the study, validated test methods will be used to determine QL1209/Pertuzumab concentrations in PK samples at different visit points after infusion administration. Non- compartmental models will be used to calculate PK parameters and perform statistical analysis. Anti-drug antibody (ADA) and titer in immunogenicity samples will be determined using a validated test method, and neutralizing antibody (Nab) will be further tested for ADA-positive samples.