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

Phase 1

Completed

• Conditions: Bioequivalence
• Interventions: Drug: RGB-02 or Neulasta® (pegfilgrastim)

• Registration Number: NCT03146988
• Lead Sponsor: Gedeon Richter Plc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Primary Completion: 2017-09-14
• Study Completion: 2017-10-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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"

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RGB-02 6 mg SC (test product)	RGB-02 or Neulasta® (pegfilgrastim)	-
Neulasta®	RGB-02 or Neulasta® (pegfilgrastim)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Ruddington, Nottingham, United Kingdom