NCT02269930

Brief Summary

The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif. The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 multiple-sclerosis

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

Study Start

First participant enrolled

October 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

October 17, 2014

Last Update Submit

January 29, 2015

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h)

    2 weeks

Secondary Outcomes (2)

  • Maximum observed serum concentration (Cmax) of BIIB017 and Rebif

    2 weeks

  • Number of participants experiencing Adverse Events (AE) and Serious Adverse Events (SAE)

    Up to 4 weeks following treatment period

Study Arms (2)

Group 1

EXPERIMENTAL

Treatment Sequence 1: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Treatment Sequence 2: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29

Drug: peginterferon beta-1aDrug: Rebif

Group 2

EXPERIMENTAL

Treatment Sequence 1: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Treatment Sequence 2: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41

Drug: peginterferon beta-1aDrug: Rebif

Interventions

peginterferon beta-1aDRUG

Administered as subcutaneous injection

Also known as: BIIB017, Plegridy
Group 1Group 2
RebifDRUG

Administered as subcutaneous injection

Group 1Group 2

Eligibility Criteria

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

You may qualify if:

  • \- Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and Day -1

You may not qualify if:

  • History or positive test result at Screening for human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\])
  • History of premalignant and malignant disease including solid tumors and hematologic malignancies
  • Known allergy to any interferon or any component of BIIB017
  • Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Evansville, Indiana, 47710, United States

Location

Related Publications (1)

  • Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B. COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):380-8. doi: 10.1111/bcp.12968. Epub 2016 May 29.

    PMID: 27060836DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

peginterferon beta-1aInterferon beta-1a

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 21, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

US(1)