NCT02479646

Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta

Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta®) in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.

Detailed description

After successful screening, each subjects will be randomly allocated to one of the following six possible sequences, according a 1:1:1:1:1:1 randomization scheme: Sequence\_1: Treatment A -\> Treatment B -\> Treatment C ; Sequence\_2: Treatment A -\> Treatment C -\> Treatment B ; Sequence\_3: Treatment B -\> Treatment A -\> Treatment C ; Sequence\_4: Treatment B -\> Treatment C -\> Treatment A ; Sequence\_5: Treatment C -\> Treatment A -\> Treatment B ; Sequence\_6: Treatment C -\> Treatment B -\> Treatment A ; In study Period 1, Subjects will be administered MYL-1401H (Treatment A), EU-Neulasta(Treatment B) or US-Neulasta (Treatment C). After the 1st crossover, subjects will enter Study period 2 and will receive one of the remaining alternate treatments. After the 2nd crossover, subjects will enter Study period 3 and will receive the other alternate treatment. The washout between drug administrations is at least 4 weeks. Final follow-up visit is scheduled 4 weeks after the last study drug administration.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	MYL-1401H
BIOLOGICAL	EU-Neulasta
BIOLOGICAL	US-Neulasta

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-06-24
• Last updated: 2022-02-14

Locations

1 site across 1 country: Netherlands