drugset / Trial / NCT04651036
A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects
RandomizedParallel-groupSingle-blindOther
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.
Timeline
- Start
- 2020-11-06
- Primary completion
- 2021-11-30
- Completion
- 2022-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
Indications
No indication recorded.