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

Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult Subjects

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.

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