drugset
drugset / Trial / NCT03146988

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

NCT03146988 ↗

Phase 1 Completed 150 enrolled Gedeon Richter Plc.
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2017-04-10
Primary completion
2017-09-14
Completion
2017-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Subject RGB-02 Unknown 6 mg Subcutaneous

Indications

No indication recorded.