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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02474134




Registration number
NCT02474134
Ethics application status
Date submitted
17/03/2015
Date registered
17/06/2015
Date last updated
16/11/2015

Titles & IDs
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
Secondary ID [1] 0 0
PF530-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1b (PF530, Betaferon)

Other: PF530/Betaferon - Single subcutaneous injection of two interferon beta-1b products (PF530 and Betaferon) 0.25 mg

Other: Betaferon/PF530 - Single subcutaneous injection of two interferon beta-1b products (Betaferon and PF530) 0.25 mg


Treatment: Drugs: Interferon beta-1b (PF530, Betaferon)
Single subcutaneous administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse event (AE) and serious adverse event (SAE) incidence
Timepoint [1] 0 0
28 Days
Secondary outcome [1] 0 0
Serum area-under-the-curve (AUC) of PF530 and Betaferon
Timepoint [1] 0 0
72 hours
Secondary outcome [2] 0 0
Serum maximum concentration (Tmax) of PF530 and Betaferon
Timepoint [2] 0 0
72 hours
Secondary outcome [3] 0 0
Serum half-life (t1/2) of PF530 and Betaferon
Timepoint [3] 0 0
72 hours
Secondary outcome [4] 0 0
Serum neopterin
Timepoint [4] 0 0
168 hours
Secondary outcome [5] 0 0
Serum myxovirus resistance protein A
Timepoint [5] 0 0
168 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfenex, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02474134
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib, MD
Address 0 0
CMAX, A Division of IDT Australia, Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02474134