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

Bioequivalence Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146988
• Other study ID #: RGB-02-001
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2017
• Last updated: November 21, 2017
• Start date: April 10, 2017
• Est. completion date: October 4, 2017

Study information

• Verified date: November 2017
• Source: Gedeon Richter Plc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 4, 2017
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioequivalence

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Gedeon Richter Plc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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