Study Stage 1:To evaluate the safety and tolerability of BaroFeron administered subcutaneously (SC)To determine the PK and PD profiles of BaroFeron administered SC and compare to Betaferon administered SCTo evaluate evidence of activity of BaroFeron…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events, pharmacokinetics, pharmacodynamics
Secondary outcome
not applicable
Background summary
BaroFeron*, a recombinant human interferon beta-1b (rhIFN beta-1b) product
developed by BaroFold, Inc., is being evaluated as a potential drug for the
treatment of relapse-remitting multiple sclerosis (RRMS) to reduce the
frequency of clinical exacerbations. Current treatments, such as the use of
the approved drug Betaferon®, are focused on slowing the progression of the
disease for which there is currently no known cure. The active pharmaceutical
ingredient (rhIFN beta-1b) in BaroFeron is chemically identical (i.e. the same
amino acid sequence) to the active pharmaceutical ingredient in Betaferon.
Betaferon is formulated with human serum albumin (HSA) and contains only 40%
monomeric rhIFN beta-1b with the remainder as aggregates or HSA complexes.
BaroFeron does not contain HSA and is >99% monomeric rhIFN beta-1b. It is
expected that the absence of significant rhIFN beta-1b aggregates in BaroFeron
will result in significantly lower immune responses in patients compared to
Betaferon. By reducing or eliminating the immune response to rhIFN beta-1b,
BaroFeron should provide the clinical benefits of prolonged efficacy and safety
for RRMS patients who presently require high dose therapy with Betaferon.
Study objective
Study Stage 1:
To evaluate the safety and tolerability of BaroFeron administered
subcutaneously (SC)
To determine the PK and PD profiles of BaroFeron administered SC and compare to
Betaferon administered SC
To evaluate evidence of activity of BaroFeron by measurement of two or more PD
markers and compare to the activity of Betaferon
Study Stage 2:
To compare the safety and tolerability of SC administered BaroFeron and
Betaferon within the same subjects
To compare the PK and PD profiles of SC administered BaroFeron and Betaferon
within the same subjects
Study design
Part 1: Partially open label, partially double blind, randomised, dose
escalation
Part 2: Double blind, randomised, cross-over
Intervention
Part 1:
Group 1 - 0.12mg BaroFeron
Group 2 - 0.25 mg BaroFeron or 0.5mg Betaferon
Group 3 - 0.5 mg BaroFeron or 0.5mg Betaferon
Part 2:
0.5mg BaroFeron or 0.5mg Betaferon (cross-over)
Study burden and risks
De risks during this trial are the possible side effects related to the study
medication.
Also the admission period, venapunctures and placing of the canula may cause a
burden to the volunteers.
Other assesments taking place during this trial: physical examination, vital
signs, blood and urine collection, pregnancy test (only for women), drugscreen,
alcoholtest, study restrictions and completion of the pain questionnaire (if
applicable)
All volunteers are being monitored by experienced physicians and study
personell
303 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
USA
303 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
USA
Listed location countries
Age
Inclusion criteria
• Age 18 to 65 years • Body Mass Index (BMI) between 18 and 28 • Negative serum pregnancy test for females of childbearing potential • Good state of health as determined by medical history, physical examination, vital signs measurement, ECG recording, and clinical laboratory tests • Willing and able to give informed consent
Exclusion criteria
• Subjects who have received treatment for any illness within 30 days of the first study drug dosing • Any active viral, bacterial or systemic fungal infection within one week of enrollment • Documented history of or current cardiovascular, renal, hepatic, or immune disorders • Liver enzymes outside laboratory normal range • Drug or alcohol use within 1 week of study entry • Positive drugs screen or alcohol breath test at screening or at admission • Immunotherapy or immunosuppressant treatment within 4 months prior to study entry • Chronic use of NSAIDs within 1 week prior to study entry • History of multiple sclerosis, optic neuritis, or myelitis • Positive serology for Hepatitis B (HBV), Hepatitis C (HCV), or HIV. Must also have no prior history of HBV or HCV virus infection • Prior history of cancer excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix • Women who are breastfeeding • Unwilling to use an effective method of contraception while on study • Unwilling to abstain from drug, alcohol and cigarette use during study participation • Any prior treatment with interferon alpha (IFN-alpha) or interferon beta (IFN-beta) therapy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-003063-39-NL |
| CCMO | NL23383.040.08 |