Comparison Study of PF530 and Betaferon in Healthy Subjects

Condition(s) targeted: Multiple Sclerosis

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

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Pfenex, Inc

Official(s) and/or principal investigator(s):
Sepehr Shakib, MD, Principal Investigator, Affiliation: CMAX, A Division of IDT Australia, Limited
Hubert C Chen, MD, Study Director, Affiliation: Pfenex, Inc

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Adverse event (AE) and serious adverse event (SAE) incidence

Secondary outcome:

Serum area-under-the-curve (AUC) of PF530 and Betaferon

Serum maximum concentration (Tmax) of PF530 and Betaferon

Serum half-life (t1/2) of PF530 and Betaferon

Serum neopterin

Serum myxovirus resistance protein A

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.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

CMAX, Adelaide, South Australia 5000, Australia

Starting date: March 2015
Last updated: June 18, 2015