Comparison Study of PF530 and Betaferon in Healthy Subjects

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfenex, Inc
• Treatments: Interferon beta-1b; Interferon-beta; Interferons

Criteria

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.