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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2017
CompletedFirst Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2017
CompletedNovember 22, 2017
November 1, 2017
5 months
April 26, 2017
November 21, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
RGB-02 6 mg SC (test product)
EXPERIMENTALNeulasta®
ACTIVE COMPARATORInterventions
Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Clinical
Ruddington, Nottingham, NG11 6JS, United Kingdom
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 10, 2017
Study Start
April 10, 2017
Primary Completion
September 14, 2017
Study Completion
October 4, 2017
Last Updated
November 22, 2017
Record last verified: 2017-11