Phase I BP Interferon (IFN) Beta-004
Information source: Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting
Intervention: Interferon beta-1a HSA-free biosimilar (Drug); Interferon beta-1a HSA+ biosimilar (Drug); Interferon beta-1a original (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Centre Hospitalier Universitaire Vaudois Official(s) and/or principal investigator(s): Jérôme Biollaz, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois
Summary
Phase I study aiming at:
- establishing the pharmacokinetic profile of interferon beta-1a after i. v.
administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free
solution in pre-filled syringes) at 18 MIU;
- investigating the possible impact of albumin on pharmacokinetic profile by comparing 3
different i. v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution
in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif®
from Merck-Serono, a registered IFN beta-1a solution containing HSA;
- establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in
HSA-free solution after 4 subsequent s. c. doses of 18 MIU given at 48 hour intervals
against Rebif® using the same regimen.
Clinical Details
Official title: Comparative Pharmacokinetic Profile of Interferon Beta-1a (Bioferon®) Administered as Single i.v. Doses in HSA-free Formulation and HSA+ Solution and as Multiple s.c. Doses in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Composite of interferon beta-1a PK parameters
Secondary outcome: Serum concentration of neopterin (PD marker)Number of participants with adverse events (AE)/serious adverse event (SAE) as a measure of safety and tolerability Composite of local reactions as a measure of local tolerance Composite of clinical laboratory tests as a measure of safety and tolerability Composite of vital signs as a measure of safety and tolerability Sickness behavior assessment Electrocardiogram (ECG) as a measure of safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and female subjects aged between 18 and 45 years
- Weight range between 55 and 95 kg for males, 45 and 80 kg for females, providing body
mass index (BMI) was between 18 and 29 kg/m2
- Absence of significant findings in the medical history and physical examination
- Absence of significant laboratory abnormalities as judged by the investigator.
- 12-lead ECG without significant abnormalities
- Negative urine drug screen
Exclusion Criteria:
- History of major renal, hepatic, immunological, haematological, gastrointestinal,
genitourinary, neurological, or rheumatological disorders
- Active diseases of any type, even if mild, including inflammatory disorders and
infections.
- Pregnant or lactating women or women contemplating becoming pregnant during study.
Female subjects of child-bearing potential who did not practice efficient
contraception during the study. A pregnancy test in blood was performed at screening
and before each period with β-human chorionic gonadotropin for females of
child-bearing potential. If pregnancy test was positive, the subject had to be
immediately excluded from study and followed until delivery
- History of severe allergy or of asthma at any time.
- History of cardiovascular dysfunction
- Hypertension
- Sick sinus syndrome or known long QT syndrome
- Presence of QTc  > 440 msec or pronounced sinus bradycardia (<40 bpm/min), even if
elicited by sport
- Dark skin preventing local tolerance assessment or abnormal cutaneous reaction e. g.
urticaria or papular dermographism
- Intense sport activities.
- Any clinically significant laboratory value on screening that were not within normal
range on single repeat
- Positive hepatitis B & C antigen screen
- Positive HIV antibody screen or screen not performed
- Any recent acute illness or sequelae thereof which could expose the subject to a
higher risk or might confound the results of the study
- Treatment in the previous three months with any drug known to have well-defined
potential for toxicity to a major organ
- History of hypersensitivity to any drug if considered as serious
- History of alcohol or drug abuse
- Positive qualitative urine drug test at screening
- Use of any medication in 2 weeks prior to study and throughout study, including
aspirin or other over-the-counter preparation.
- Blood (500 mL) donation or hemorrhage during the previous three months
- Participation in a clinical trial in the previous 3 months
- Smoking
- Consumption of a large quantity of coffee, tea or equivalent
- Present consumption of a large quantity of alcohol or wine or equivalent
- Psychological status which could have had an impact on subject's ability to give
informed consent or behavioral tests
- Any feature of subject's medical history or present condition which, in the
investigator's opinion, could confound the results of the study, complicate its
interpretation, or represent a potential risk for the subject
Locations and Contacts
Additional Information
Starting date: May 2006
Last updated: August 7, 2015
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