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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area
Quotient Clinical
Ruddington, Nottingham, United Kingdom
Pharmacokinetic parameter: AUC0-inf
Area under the serum concentration vs time curve from dosing to the last measured time point
Time frame: 67 days
Pharmacokinetic parameter: Cmax
Time frame: 67 days
Pharmacodynamic parameter: ANCmax
Time frame: 67 days
Pharmacodynamic parameter: ANC AOBEC0-tlast
Time frame: 67 days
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