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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

Page last updated: August 23, 2015

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