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OpenTrials
Completed

NCT Number: NCT03146988

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

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.

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Key information

Conditions

Bioequivalence

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGB-02 or Neulasta® (pegfilgrastim)

Drug

Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area

Primary outcomes

  1. Pharmacokinetic parameter: AUC0-inf

    Time frame: 67 days

    Area under the serum concentration vs time curve from dosing to the last measured time point

  2. Pharmacokinetic parameter: Cmax

    Time frame: 67 days

  3. Pharmacodynamic parameter: ANCmax

    Time frame: 67 days

  4. Pharmacodynamic parameter: ANC AOBEC0-tlast

    Time frame: 67 days

Sponsors and collaborators

Lead sponsor

Gedeon Richter Plc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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