Phase I BP Interferon (IFN) Beta-004

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborator: BioPartners GmbH
• Treatments: Interferon beta-1a; Interferon-beta; Interferons; Pharmaceutical Solutions

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