Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta

• Status: Completed
• Trial end date: 2017-10-04
• Target enrollment: 0
• Participant gender: All

Summary

Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gedeon Richter Plc.

Criteria

Inclusion Criteria:

• Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years

• Body mass index ≥19.0 to ≤30.0 kg/m2

• Body weight >55 kg"

Exclusion Criteria:

• Prior exposure to filgrastim, pegfilgrastim or lenograstim (Period 1 only)

• Subjects who have received any IMP in a clinical research study within the previous 3 months

• History of any drug or alcohol abuse in the past 2 years

• Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

• Current smokers who smoke more than 10 cigarettes per day

• Positive drugs of abuse test result

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients