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Phase I BP Interferon (IFN) Beta-001

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 (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:

- assessing the absolute bioavailability, pharmacokinetic profile, and dose

proportionality of interferon beta-1a (HSA-free solution in pre-filled syringes) after i. v. and s. c. administration as well as the pharmacodynamic profile to create the link with available surrogate markers investigated with both formulations used clinically, lyophilisate with HSA (HSA+) and solution without HSA (HSA-);

- gathering further information on safety and tolerability of interferon beta-1a over

dose range,including local and systemic tolerance, body temperature, vital signs, and a battery of exploratory sickness behavior tests.

Clinical Details

Official title: Bioavailability, Pharmacokinetic and Pharmacodynamic Profile of Interferon Beta-1a (Bioferon) Administered i.v. and s.c. as Single Doses to 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

Composite of interferon beta-1a PD markers

Secondary outcome:

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 2005
Last updated: August 4, 2015

Page last updated: August 23, 2015

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