Comparison Study of PF530 and Betaferon in Healthy Subjects

NCT02474134 | Completed Phase 1

• 1 other identifier: PF530-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Adverse event (AE) and serious adverse event (SAE) incidence

  28 Days

Secondary Outcomes (5)

• 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

Study Arms (2)

PF530/Betaferon

OTHER

Single subcutaneous injection of two interferon beta-1b products (PF530 and Betaferon) 0.25 mg

Drug: Interferon beta-1b (PF530, Betaferon)

Betaferon/PF530

OTHER

Single subcutaneous injection of two interferon beta-1b products (Betaferon and PF530) 0.25 mg

Drug: Interferon beta-1b (PF530, Betaferon)

Interventions

Interferon beta-1b (PF530, Betaferon) DRUG

Single subcutaneous administration

Also known as: PF530, Betaferon

Betaferon/PF530; PF530/Betaferon

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfenex, Inc: lead

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Sepehr Shakib, MD

  CMAX, A Division of IDT Australia, Limited

  PRINCIPAL INVESTIGATOR

• Hubert C Chen, MD

  Pfenex, Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: June 17, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

AU (1)