Comparison Study of PF530 and Betaferon in Healthy Subjects

A Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult Volunteers

The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Interferon beta-1b (PF530, Betaferon)

Detailed Description

This is a double-blind, randomised, two-treatment cross-over study in healthy adult subjects to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of PF530 and Betaferon. Half of the subjects will be randomised to receive PF530 first and Betaferon second, and the other half will be randomised to receive the drugs in reverse sequence. Each study participant will complete two 7-day study periods (Period 1 and Period 2), separated by a 14-day washout period. In Part I of the study, 12 subjects will be enrolled for an initial assessment. In Part II, up to 36 additional subjects may be enrolled.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
• Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
• Participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
• Able to understand and sign the written Informed Consent Form

Exclusion Criteria:

• Female subjects who are pregnant or lactating.
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
• Previous treatment with any interferon product, including investigational use.
• Participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
• Positive screening test for human immunodeficiency virus (HIV).
• Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis surface antigen [HBsAg] at Screening). Participants with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody [HBsAb]) are eligible to participate in the study.
• History of epilepsy, seizure disorder or any unexplained black-outs.
• History of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (NSAID) that would preclude the use of at least 1 of these during the study.
• History of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
• History of drug or alcohol abuse less than or equal to 12 months prior to Screening.
• History of tobacco use less than or equal to 6 months prior to Screening.
• A positive test for drugs of abuse or alcohol during Screening or prior to dosing.
• Unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
• Use of any prescription medication, over-the-counter medication, or herbal supplements/products during Screening or throughout study, unless approved by both the Principal Investigator and the Sponsor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PF530/Betaferon; Single subcutaneous injection of two interferon beta-1b products (PF530 and Betaferon) 0.25 mg	Drug: Interferon beta-1b (PF530, Betaferon); Single subcutaneous administration; Other Names: PF530, Betaferon
Other: Betaferon/PF530; Single subcutaneous injection of two interferon beta-1b products (Betaferon and PF530) 0.25 mg	Drug: Interferon beta-1b (PF530, Betaferon); Single subcutaneous administration; Other Names: PF530, Betaferon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse event (AE) and serious adverse event (SAE) incidence	28 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum area-under-the-curve (AUC) of PF530 and Betaferon	72 hours
Serum maximum concentration (Tmax) of PF530 and Betaferon	72 hours
Serum half-life (t1/2) of PF530 and Betaferon	72 hours
Serum neopterin	168 hours
Serum myxovirus resistance protein A	168 hours

Collaborators and Investigators

• Sponsor: Pfenex, Inc
• Investigators: Study Director: Hubert C Chen, MD, Pfenex, Inc; Principal Investigator: Sepehr Shakib, MD, CMAX, A Division of IDT Australia, Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 17, 2015

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon-beta; Interferon beta-1b
• Other Study ID Numbers: PF530-101