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

Completed

Conditions: infection
reduced white blood cell count
10018849

Registration Number: NL-OMON45253

Lead Sponsor: Hexal AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 136

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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