Comparison Study of PF530 and Betaferon in Healthy Subjects

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474134
• Other study ID #: PF530-101
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2015
• Last updated: November 13, 2015
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Pfenex, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Interferon beta-1b (PF530, Betaferon)
Single subcutaneous administration

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Pfenex, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event (AE) and serious adverse event (SAE) incidence		28 Days	Yes
Secondary	Serum area-under-the-curve (AUC) of PF530 and Betaferon		72 hours	No
Secondary	Serum maximum concentration (Tmax) of PF530 and Betaferon		72 hours	No
Secondary	Serum half-life (t1/2) of PF530 and Betaferon		72 hours	No
Secondary	Serum neopterin		168 hours	No
Secondary	Serum myxovirus resistance protein A		168 hours	No