A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects

Completed

• Conditions: 10018849; 10027665; infection; reduced white blood cell count

• Registration Number: NL-OMON43539
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 184

Inclusion Criteria

- healthy male and female volunteers
- age 18 - 45 inclusive
- BMI between 19.0 and 28.0 kilograms/meter2
- 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>To determine bioequivalence of LA-EP2006 and Neulasta® EU following a single 6<br /><br>mg subcutaneous (s.c.) injection in terms of the pegfilgrastim pharmacokinetic<br /><br>parameters AUC0** and Cmax.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to further compare LA-EP2006 and Neulasta® EU with<br /><br>respect to:<br /><br>* Pharmacokinetic parameters AUC0*last, tmax, and t*<br /><br>* Absolute neutrophil count (ANC) response as assessed by AUEC(0-336h), Emax,<br /><br>tmax,E<br /><br>* Safety, immunogenicity, and local tolerance </p><br>