HealthyPhase 1NCT01610310

Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers

A Phase 1 study testing BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS) and BIIB017 (peginterferon beta-1a) Autoinjector in people with Healthy and Multiple Sclerosis, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Multiple Sclerosis
What is being tested?: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS) and BIIB017 (peginterferon beta-1a) Autoinjector
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Oct 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Saint Paul, Minnesota

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) Delivered by Pre-filled Syringe (PFS) or Autoinjector in Healthy Volunteers

Read the detailed description

This is a randomized, open-label, 2-sequence, 2-period crossover study that will be conducted at a single site in the United States to characterize the PK profile, safety and tolerability of peginterferon beta-1a delivered by autoinjector or PFS. Participants will be randomized in a 1:1 ratio to receive a single dose of peginterferon beta-1a at Day 1 delivered by either autoinjector or PFS, followed by a single dose of peginterferon beta 1a delivered by the other device at Day 22. The total duration of study participation is up to 3 months for each participant. Participants will complete a follow-up visit at Day 50 after the end of treatment period.

Conditions: Healthy, Multiple Sclerosis
Being tested: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector
Keywords: SC, PEG, Inteferon, PK, Subcutaneous, PEGylated, Autoinjector, Injectable, MS
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)Device
Also called BIIB017
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
BIIB017 (peginterferon beta-1a) AutoinjectorDevice
Also called BIIB017
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22

Study groups in NCT01610310
Study group	Role	What they receive
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. Receives: 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. Receives: Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS); Device: BIIB017 (peginterferon beta-1a) Autoinjector

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)
Measured: For 11 days (multiple timepoints) after each dose on Day 1 and 22

Secondary outcomes (7)

Maximum Serum Concentration (Cmax) of peginterferon beta-1a
Measured: 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)
Measured: Day 1 up to Day 50
Changes in clinical laboratory assessments
Measured: Day 1 up to Day 50
Vital sign changes
Measured: Day 1 up to Day 50)
Physical exam changes
Measured: Day 1 up to Day 50
Electrocardiogram changes
Measured: Day 1 up to Day 50
Clinician injection site assessment
Measured: Days 1+2, 22+23

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Oct 2012

First posted4 Jun 2012 (estimated)
Study startJun 2012
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01610310
Sponsor's protocol ID: 105HV103
Status last verified: Jun 2014
First submitted: 31 May 2012
Last updated: 13 Jun 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) Delivered by Pre-filled Syringe (PFS) or Autoinjector in Healthy Volunteers
ClinicalTrials.gov ID: NCT01610310
Acronym / sponsor ID: 105HV103
Conditions: Healthy, Multiple Sclerosis
Keywords: SC, PEG, Inteferon, PK, Subcutaneous, PEGylated, Autoinjector, Injectable
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 4 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
peginterferon beta-1a PFS/autoinjector	Experimental	Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), Device: BIIB017 (peginterferon beta-1a) AutoinjectorA 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.
peginterferon beta-1a autoinjector / PFS	Experimental	Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), Device: BIIB017 (peginterferon beta-1a) AutoinjectorA 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.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)Also: BIIB017125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22	Device	peginterferon beta-1a PFS/autoinjector, peginterferon beta-1a autoinjector / PFS
BIIB017 (peginterferon beta-1a) AutoinjectorAlso: BIIB017125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22	Device	peginterferon beta-1a PFS/autoinjector, peginterferon beta-1a autoinjector / PFS

Primary outcome

Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)
Time frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22

7 secondary outcomes

Maximum Serum Concentration (Cmax) of peginterferon beta-1a
Time frame: 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)
Time frame: Day 1 up to Day 50
Changes in clinical laboratory assessments
Time frame: Day 1 up to Day 50
Vital sign changes
Time frame: Day 1 up to Day 50)
Physical exam changes
Time frame: Day 1 up to Day 50
Electrocardiogram changes
Time frame: Day 1 up to Day 50
Clinician injection site assessment
Time frame: Days 1+2, 22+23

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞) (time frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01610310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.