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Comparative Study of QL1209 and Perjeta® in Healthy Male Participants

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07861139
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Breast Cancer
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov