Comparison Study of PF530 and Betaferon in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 23 November 2015
• Main ID: NCT02474134
• Date of registration: 17/03/2015
• Prospective Registration: No
• Primary sponsor: Pfenex, Inc
• Public title: Comparison Study of PF530 and Betaferon in Healthy Subjects
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02474134
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Sepehr Shakib, MD
• Affiliation: CMAX, A Division of IDT Australia, Limited

• Name: Hubert C Chen, MD
• Affiliation: Pfenex, Inc

Key inclusion & exclusion 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 ß-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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

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

Primary Outcome(s)

Adverse event (AE) and serious adverse event (SAE) incidence [Time Frame: 28 Days]

Secondary Outcome(s)

Serum neopterin [Time Frame: 168 hours]

Serum area-under-the-curve (AUC) of PF530 and Betaferon [Time Frame: 72 hours]

Serum half-life (t1/2) of PF530 and Betaferon [Time Frame: 72 hours]

Serum myxovirus resistance protein A [Time Frame: 168 hours]

Serum maximum concentration (Tmax) of PF530 and Betaferon [Time Frame: 72 hours]

Secondary ID(s)

PF530-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors