Comparison Study of PF530 and Betaferon in Healthy Subjects
Information source: Pfenex, Inc
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 BetaferonSerum 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.
Eligibility
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.
Locations and Contacts
CMAX, Adelaide, South Australia 5000, Australia
Additional Information
Starting date: March 2015
Last updated: June 18, 2015
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