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

PHASE1CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 10, 2017

Primary Completion Date

September 14, 2017

Study Completion Date

October 4, 2017

Conditions
Bioequivalence
Interventions
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

Trial Locations (1)

NG11 6JS

Quotient Clinical, Ruddington

Sponsors
All Listed Sponsors
lead

Gedeon Richter Plc.

INDUSTRY

NCT03146988 - Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta | Biotech Hunter | Biotech Hunter