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

NCT04651036 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-12-03

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

QL0605

a pegfilgrastim biosimilar to US Neulasta.

DRUG

US Neulasta

US Neulasta

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Thomas Koernicke, MD · Parexel International GmbH Early Phase Clinical Unit Berlin

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2021-11-30
Completion
2022-11-30

Countries

  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651036 on ClinicalTrials.gov