A randomized, double-blind, three-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single 6 mg subcutaneous administration of the proposed biosimilar product LA-EP2006, Neulasta® US and Neulasta® EU in healthy subjects

A randomized, double-blind, three-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single 6 mg subcutaneous administration of the proposed biosimilar product LA-EP2006, Neulasta® US and Neulasta® EU in healthy subjects - PK bioequivalence, PD equivalence of LA-EP2006, Neulasta US and Neulasta EU

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45253

Enrollment

136

Registered

2017-08-29

Start date

2017-04-14

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

infection reduced white blood cell count

Interventions

The volunteer will receive one single injection of 6 mg LA-EP2006 diluted in 0.6 mL solution during one period, one single injection of 6 mg Neulasta®US diluted in 0.6 mL solution during other perio

double-blind

safety

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - healthy male and female volunteers - age 18 - 55 years, inclusive - BMI 19.0 - 30.0 kg/m2, inclusive - weight * 60 kg

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 12 weeks from the start of the study.

Design outcomes

Primary

Measure	Time frame
The primary objective for this study is to demonstrate PK similarity in terms of pegfilgrastim AUC0-inf, AUC0-last and Cmax as well as PD similarity based on ANC AUEC0-last and ANC Emax between: - LA-EP2006 and Neulasta® US - LA-EP2006 and Neulasta® EU - Neulasta® US and Neulasta® EU following a single 6 mg subcutaneous (s.c.) injection in healthy male and female subjects. The PK and PD primary endpoints will be tested as co-primary endpoints for all pairwise comparisons among LA-EP2006, Neulasta® US and Neulasta® EU. The similarity for both, PK and PD among the three treatment groups will be statistically demonstrated only if the 90% CIs for geometric mean ratios of all co-primary endpoints and for all pairwise comparisons among LA-EP2006, Neulasta® US and Neulasta® EU are contained within the predefined equivalence margins of 0.8 to 1.25.	—

Measure

Time frame

The primary objective for this study is to demonstrate PK similarity in terms of pegfilgrastim AUC0-inf, AUC0-last and Cmax as well as PD similarity based on ANC AUEC0-last and ANC Emax between: - LA-EP2006 and Neulasta® US - LA-EP2006 and Neulasta® EU - Neulasta® US and Neulasta® EU following a single 6 mg subcutaneous (s.c.) injection in healthy male and female subjects. The PK and PD primary endpoints will be tested as co-primary endpoints for all pairwise comparisons among LA-EP2006, Neulasta® US and Neulasta® EU. The similarity for both, PK and PD among the three treatment groups will be statistically demonstrated only if the 90% CIs for geometric mean ratios of all co-primary endpoints and for all pairwise comparisons among LA-EP2006, Neulasta® US and Neulasta® EU are contained within the predefined equivalence margins of 0.8 to 1.25.

—

Secondary

Measure	Time frame
The secondary objectives of the study are to evaluate/compare LA-EP2006 with Neulasta® US, LA-EP2006 with Neulasta® EU and Neulasta® US with Neulasta® EU following a single 6 mg s.c. injection in healthy male and female subjects in terms of: - Descriptive statistics for PK (tmax and t1/2), and PD ANC tmax,E parameters. - Safety, immunogenicity, and local tolerance.	—

Countries

Netherlands, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)