Overview

A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects

Status:
Recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Qilu Pharmaceutical Co., Ltd. proposed biosimilar QL0605 compared to innovator product, US-Neulasta) in healthy, adult, human subjects.
Phase:
Phase 1
Details
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.