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

Gedeon Richter

Status and phase: Completed; Phase 1

Conditions: Bioequivalence

Treatments: Drug: RGB-02 or Neulasta® (pegfilgrastim)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03146988

RGB-02-001

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

RGB-02 6 mg SC (test product)

Experimental group

Treatment:

Drug: RGB-02 or Neulasta® (pegfilgrastim)

Neulasta®

Active Comparator group

Treatment:

Drug: RGB-02 or Neulasta® (pegfilgrastim)