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

Healthy Clinical Trial

Official title:
A Randomized, Double-blind, 2-period Parallel-arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of QL0605 (6 mg) Compared to 2 Subcutaneous Doses of US Neulasta P®P (6 mg) in Healthy Male and Female Subjects

Clinical Trial 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.

Clinical Trial Description

This is a multi-center, randomized, double-blind, single-dose, 2-period parallel-arm study designed to assess the immunogenicity of QL0605 and US-Neulasta. A total of 300 healthy male and female subjects aged 18-55 years (inclusive) will be included and randomized to receive either 2 s.c. doses of QL0605 or US-NeulastaP®P in a ratio of 1:1. After the Screening Period of up to 4 weeks the subject will be randomly allocated to one of the 2 parallel treatment arms. All subjects will receive 1 s.c. injection of 6 mg QL0605 or 6 mg NeulastaP®P (US) in Treatment Period 1 and 1 s.c. injection of 6 mg QL0605 or 6 mg NeulastaP®P in Treatment Period 2. The interval between doses is ≥ 42 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04651036
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact Thomas Koernicke, MD
Phone +49 (0)30 30685 9676
Email Thomas.Koernicke@parexel.com
Status Recruiting
Phase Phase 1
Start date November 6, 2020
Completion date November 30, 2022
View Details
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