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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03146988

Enrollment

150

Registered

2017-05-10

Start date

2017-04-10

Completion date

2017-10-04

Last updated

2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence

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.

Interventions

DRUGRGB-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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026