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A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: BIIB017 (PEGylated Interferon Beta-1a) (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen


The primary objectives are to identify the highest safe and well-tolerated dose and frequency of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of 63 to 188 mcg, when given every other week or every 4 weeks to healthy volunteers (HV).

Clinical Details

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Ranging, Parallel-Group Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

The number of participants that experience Adverse Events (AEs)

The number of participants that experience flu-like symptoms

Participant assessment of injection site pain as measured by scores on a scale of 0 to 10, where 0 is no pain and 10 is extremely painful.

Clinician assessment of the injection site for erythema as assessed by a scale 0 to 3, where 0 represents no erythema and 3 represents severe erythema

Clinician assessment of the injection site for induration as assessed by a scale 0 to 3, where 0 represents no induration and 3 represents severe induration

Clinician assessment of tenderness to digital pressure at the injection site will be assessed on a scale of 0 to 3, where 0 represents no tenderness and 3 represents severe tenderness

Clinician assessment of temperature at the injection site will be assessed on a scale of 0 to 2, where 0 represents normal temperature and 2 represents hot.

Secondary outcome:

AUC168h, area under the concentration-time curve

Cmax, observed maximum serum concentration

Tmax, time to reach maximum serum concentration

Terminal t½, half-life of the terminal phase

EAUC-336h, area under the concentration-time curve from time zero to 336 hours post-dose

Emax, the peak concentration observed minus baseline concentration

PD parameters of serum concentrations of neopterin


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


Key Inclusion Criteria:

- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive, and a minimum body weight of 50. 0

kg at screening.

- All male subjects and female subjects of child-bearing potential must be willing and

able to practice effective birth control during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. Key Exclusion Criteria:

- Abnormal screening and baseline blood and urine tests determined to be clinically

significant by the Investigator.

- Hematologic or hepatic enzyme laboratory values that were outside the normal range.

- History of severe allergic or anaphylactic reactions.

- History of any clinically-significant (as determined by the Investigator) cardiac,

endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, and/or history of seizure disorder.

- A family history of MS in a first-degree relative.

- A fever (body temperature >38°C) or symptomatic viral or bacterial infection

(including upper respiratory infection) within 1 week prior to Day 1.

- Abnormal ECG values as determined by the Investigator.

- Positive test result for hepatitis C antibody, hepatitis B surface antigen (HBsAg),

or human immunodeficiency virus (HIV) antibody.

- Female subjects who are considering pregnancy, currently pregnant or breastfeeding.

- Subjects who received a tattoo or body piercing (including earring) within 60 days of

baseline or subjects who are considering getting a tattoo or body piercing (including earring) in the next 60 days.

- Use of any prescription or non-prescription medication that could inhibit bone marrow

or liver function.

- Any previous treatment with any interferon product.

- Participation in any other investigational drug study within the 4 weeks prior to Day

1 or within 5 half-lives of the investigational treatment, whichever is longer.

- Treatment with the Flu Vaccine within 1 week prior to Day 1.

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

Locations and Contacts

Research Site, Phoenix, Arizona, United States
Additional Information

Starting date: March 2008
Last updated: April 25, 2014

Page last updated: August 23, 2015

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