NCT03146988

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Gedeon Richter Plc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	RGB-02 or Neulasta® (pegfilgrastim)	Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area

Timeline

• Start date: 2017-04-10
• Primary completion: 2017-09-14
• Completion: 2017-10-04
• First posted: 2017-05-10
• Last updated: 2017-11-22

Locations

1 site across 1 country: United Kingdom