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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: RGB-02 or Neulasta® (pegfilgrastim)

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RGB-02 6 mg SC (test product)	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
Active Comparator: Neulasta®	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter: AUC0-inf	Area under the serum concentration vs time curve from dosing to the last measured time point	67 days
Pharmacokinetic parameter: Cmax		67 days
Pharmacodynamic parameter: ANCmax		67 days
Pharmacodynamic parameter: ANC AOBEC0-tlast		67 days

Collaborators and Investigators

• Sponsor: Gedeon Richter Plc.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): September 14, 2017
• Study Completion (Actual): October 4, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RGB-02-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No