NCT01610310

Brief Summary

The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers to support the development of the autoinjector.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

May 31, 2012

Last Update Submit

June 12, 2014

Conditions

HealthyMultiple Sclerosis

Keywords

SCPEGInteferonPKSubcutaneousPEGylatedAutoinjectorInjectableMS

Outcome Measures

Primary Outcomes (1)

  • Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)

    For 11 days (multiple timepoints) after each dose on Day 1 and 22

Secondary Outcomes (7)

  • Maximum Serum Concentration (Cmax) of peginterferon beta-1a

    For 11 days (multiple timepoints) after each dose on Day 1 and 22

  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Day 1 up to Day 50

  • Changes in clinical laboratory assessments

    Day 1 up to Day 50

  • Vital sign changes

    Day 1 up to Day 50)

  • Physical exam changes

    Day 1 up to Day 50

  • +2 more secondary outcomes

Study Arms (2)

peginterferon beta-1a PFS/autoinjector

EXPERIMENTAL

A single dose of peginterferon beta-1a 125 mcg administered by prefilled syringe (PFS) on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by autoinjector on Day 22.

Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)Device: BIIB017 (peginterferon beta-1a) Autoinjector

peginterferon beta-1a autoinjector / PFS

EXPERIMENTAL

A single dose of peginterferon beta-1a 125 mcg administered by autoinjector on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by prefilled syringe (PFS) on Day 22.

Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)Device: BIIB017 (peginterferon beta-1a) Autoinjector

Interventions

BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)DEVICE

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22

Also known as: BIIB017
peginterferon beta-1a PFS/autoinjectorpeginterferon beta-1a autoinjector / PFS
BIIB017 (peginterferon beta-1a) AutoinjectorDEVICE

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22

Also known as: BIIB017
peginterferon beta-1a PFS/autoinjectorpeginterferon beta-1a autoinjector / PFS

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Must have a body mass index (BMI) of 19 to 29 kg/m\^2, inclusive, and a minimum body weight of 50.0 kg

You may not qualify if:

  • History of any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
  • Female subjects who are pregnant or breastfeeding
  • Any previous treatment with prescription or investigational pegylated drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Saint Paul, Minnesota, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations

US(1)