Phase I BP Interferon (IFN) Beta-001

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2015
• Main ID: NCT02515695
• Date of registration: 24/07/2015
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Universitaire Vaudois
• Public title: Phase I BP Interferon (IFN) Beta-001
• Scientific title: Bioavailability, Pharmacokinetic and Pharmacodynamic Profile of Interferon Beta-1a (Bioferon®) Administered i.v. and s.c. as Single Doses to Healthy Subjects
• Date of first enrolment: May 2005
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02515695
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Contacts

• Name: Jérôme Biollaz, MD
• Affiliation: Centre Hospitalier Universitaire Vaudois

Key inclusion & exclusion 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 ß-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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Interferon beta-1a

Primary Outcome(s)

Composite of interferon beta-1a PD markers [Time Frame: 0, 6, 12, 24, 48, 72, 96, 120, 168 [hours post-dose]]

Composite of interferon beta-1a PK parameters [Time Frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 [hours post-dose]]

Secondary Outcome(s)

Composite of clinical laboratory tests as a measure of safety and tolerability [Time Frame: Screening and 0, 24 [hours post-dose]]

Electrocardiogram (ECG) as a measure of safety and tolerability [Time Frame: Screening and 0, 8 [hours post-dose]]

Composite of local reactions as a measure of local tolerance [Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 [hours post-dose] and then daily if needed until Day 5 or longer until resolution in case of local reaction]

Number of participants with adverse events (AE)/serious adverse event (SAE) as a measure of safety and tolerability [Time Frame: Up to Day 7]

Composite of vital signs as a measure of safety and tolerability [Time Frame: Screening and 0, 1, 2, 4, 6, 8, 10, 12, 24 [hours post-dose]]

Sickness behavior assessment [Time Frame: 0, 2, 4, 6, 8, 10, 12 [hours post-dose]]

Secondary ID(s)

CE 92/05

2005DR1151

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BioPartners GmbH