Single centre, randomised, open-label, 2-dose, parallel trial to compare immunogenicity, safety, tolerability, and pharmacodynamics of MYL-1401H and US-licensed Pegfilgastrim (NEULASTA®) after two subcutaneous (SC) injections at one dose level (6 MG) in healthy subjects.
Completed
- Conditions
- Neutropenia10047954
- Registration Number
- NL-OMON42699
- Lead Sponsor
- Mylan GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
healthy male or female subjects
18 - 65 years of age, inclusive
BMI 19.0 - 30.0 kilograms/meter2
weight at least 60.0 kilograms
non-smoking or smoke maximally 5 cigarettes per day
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Immunogenicity/safety/tolerability/pharmacodynamics; side effects, lab data,<br /><br>vital signs, ECG and physical examination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Immunogenicity: Serum ADA concentrations<br /><br>Pharmacodynamics : Absolute neutrophil count (ANC) in periods 1 and 2: area<br /><br>under the effective concentration-time curve (AUEC) and ANCmax and derived PD<br /><br>parameters (AUEC0-t, Cmax and tmax)</p><br>