Clinical trial NCT02125578: A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: The number of participants that experience Adverse Events (AEs)
timeFrame: Up to Day 71
measure: The number of participants that experience flu-like symptoms
timeFrame: Up to Day 71
measure: 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.
timeFrame: Up to Day 71
measure: 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
timeFrame: Up to Day 71
measure: 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
timeFrame: Up to Day 71
measure: 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
timeFrame: Up to Day 71
measure: 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.
timeFrame: Up to Day 71
Secondary outcomes:
measure: AUC168h, area under the concentration-time curve
timeFrame: Up to 168 hours post dose
measure: Cmax, observed maximum serum concentration
timeFrame: Up to 336 hours post-dose
measure: Tmax, time to reach maximum serum concentration
timeFrame: Up to 336 hours post-dose
measure: Terminal t½, half-life of the terminal phase
timeFrame: Up to 336 hours post-dose
measure: EAUC-336h, area under the concentration-time curve from time zero to 336 hours post-dose
timeFrame: Up to 336 hours post-dose
measure: Emax, the peak concentration observed minus baseline concentration
timeFrame: Day 1 and Day 29
measure: PD parameters of serum concentrations of neopterin
timeFrame: Day 1 and Day 29
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.