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

NCT02125578 | Completed Phase 1

• 1 other identifier: 105HV102
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• The number of participants that experience Adverse Events (AEs)

  Up to Day 71

• The number of participants that experience flu-like symptoms

  Up to Day 71

• 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.

  Up to Day 71

• 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

  Up to Day 71

• 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

  Up to Day 71

• 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

  Up to Day 71

• 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.

  Up to Day 71

Secondary Outcomes (7)

• AUC168h, area under the concentration-time curve

  Up to 168 hours post dose

• Cmax, observed maximum serum concentration

  Up to 336 hours post-dose

• Tmax, time to reach maximum serum concentration

  Up to 336 hours post-dose

• Terminal t½, half-life of the terminal phase

  Up to 336 hours post-dose

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

  Up to 336 hours post-dose

Study Arms (3)

BIIB017 (PEGylated Interferon Beta-1a)

EXPERIMENTAL

Varying doses (63 mcg up to 188 mcg) of BIIB017 will be administered SC every other week for a total of 6 weeks.

Drug: BIIB017 (PEGylated Interferon Beta-1a)

BIIB017 (PEGylated Interferon Beta-1a) and Placebo

EXPERIMENTAL

Varying doses (63 mcg up to 188 mcg) of BIIB017 will be administered SC every 4 weeks for a total of 6 weeks. To ensure blinding, each subject will receive placebo every other week.

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

Placebo

PLACEBO COMPARATOR

Placebo dose will be administered SC every other week for a total of 6 weeks.

Drug: BIIB017 (PEGylated Interferon Beta-1a)

Interventions

BIIB017 (PEGylated Interferon Beta-1a) DRUG

Each participant will receive BIIB017 every other week or every 4 weeks.

BIIB017 (PEGylated Interferon Beta-1a); BIIB017 (PEGylated Interferon Beta-1a) and Placebo; Placebo

Placebo DRUG

Each participant will receive placebo every other week or every 4 weeks.

BIIB017 (PEGylated Interferon Beta-1a) and Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Phoenix, Arizona, United States

Location

Related Publications (1)

• Hu X, Miller L, Richman S, Hitchman S, Glick G, Liu S, Zhu Y, Crossman M, Nestorov I, Gronke RS, Baker DP, Rogge M, Subramanyam M, Davar G. A novel PEGylated interferon beta-1a for multiple sclerosis: safety, pharmacology, and biology. J Clin Pharmacol. 2012 Jun;52(6):798-808. doi: 10.1177/0091270011407068. Epub 2011 Jun 16.

  PMID: 21680782 RESULT

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 29, 2014
• Study Start: March 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

US (1)