MedDataX Logo

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

NCT ID: NCT03146988

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2017-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bioequivalence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RGB-02 6 mg SC (test product)

Group Type EXPERIMENTAL

RGB-02 or Neulasta® (pegfilgrastim)

Intervention Type DRUG

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

Neulasta®

Group Type ACTIVE_COMPARATOR

RGB-02 or Neulasta® (pegfilgrastim)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gedeon Richter Plc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Quotient Clinical

Ruddington, Nottingham, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RGB-02-001

Identifier Type: -

Identifier Source: org_study_id