NCT02474134

Comparison Study of PF530 and Betaferon in Healthy Subjects

A Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfenex, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.

Detailed description

This is a double-blind, randomised, two-treatment cross-over study in healthy adult subjects to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of PF530 and Betaferon. Half of the subjects will be randomised to receive PF530 first and Betaferon second, and the other half will be randomised to receive the drugs in reverse sequence. Each study participant will complete two 7-day study periods (Period 1 and Period 2), separated by a 14-day washout period. In Part I of the study, 12 subjects will be enrolled for an initial assessment. In Part II, up to 36 additional subjects may be enrolled.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Interferon beta-1b (PF530, Betaferon)	Single subcutaneous administration

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-06-17
• Last updated: 2015-11-16

Locations

1 site across 1 country: Australia