NCT04651036

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	QL0605	a pegfilgrastim biosimilar to US Neulasta.
DRUG	US Neulasta	US Neulasta

Timeline

• Start date: 2020-11-06
• Primary completion: 2021-11-30
• Completion: 2022-11-30
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

2 sites across 2 countries: Germany, United Kingdom