Compare PK/PD of study drug and Neulasta® at 2 mg dose (QCL115655)
Research type
Research Study
Full title
A Randomised, Double-Blind, Two-Treatment, Two-Period, Two-Sequence, Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of a Single Subcutaneous Injection of 2 mg USV Pegfilgrastim and 2 mg Neulasta® (EU approved) in Healthy Male Subjects
IRAS ID
213512
Contact name
Bharti Bilolikar
Contact email
Sponsor organisation
USV Private Ltd
Eudract number
2016-003157-15
Duration of Study in the UK
0 years, 2 months, 25 days
Research summary
The Sponsor is developing the study drug, USV pegfilgrastim, for use in the potential treatment of neutropenia. People with neutropenia have an unusually low number of white blood cells called neutrophils. Neutrophils are cells that help the body fight infection. Neutropenia is often caused by drugs used to treat cancer.
The purpose of the study is to show that the study drug is similar to that of an already licensed product, Neulasta®. The study will also aim to gather further safety and tolerability data.
The study will consist of 2 periods involving up to 64 healthy male subjects. Subjects will receive a single dose of the study drug and Neulasta® separated by a break of 28 days. Each drug will be administered as a 2 mg injection into the stomach.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0390
Date of REC Opinion
4 Oct 2016
REC opinion
Further Information Favourable Opinion