Phase I BP Interferon (IFN) Beta-004

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

CompletedPhase 1Relapsing MSNCT02517788

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

Compared with

What it measured

Main measures

  • Composite of interferon beta-1a PK parameters

    Part A: 0, 2, 5, 10, 15, 20 [min post-dose] and 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 [hours post-dose] / Part B: 0, 1, 2, 3, 4, 6, 12 [hours post-doses] and 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120

    MRI lesionsImmune responseHow the body handles the medicine

Other measures (7)

  • Serum concentration of neopterin (PD marker)

    Part A: 0, 6, 12, 24, 48, 72, 168 [hours post-doses] / Part B: 0, 6, 12 [hours post-doses] and 0, 6, 12, 24, 48, 72, 96, 120, 144, 168 [hours post-last dose] (Day 7)

    How the body handles the medicine

  • Number of participants with adverse events (AE)/serious adverse event (SAE) as a measure of safety and tolerability

    Up to Day 7

    Safety

  • Composite of local reactions as a measure of local tolerance

    Part A: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 [hours post-dose] and longer if needed and until resolution in case of local reaction / Part B: 0, 1, 2, 4, 6, 12 [hours post-dose] on Day 1 and 7, else daily

    Safety

  • Composite of clinical laboratory tests as a measure of safety and tolerability

    Screening and 0, 24 [hours post-doses]

    Safety

  • Composite of vital signs as a measure of safety and tolerability

    Part A: Screening and 0, 1, 2, 3, 4, 6, 8, 10, 12, 24 [hours post-dose] / Part B: Screening and 0, 1, 2, 3, 4, 6, 12 [hours post-doses], as well as 0, 1, 2, 3, 4, 6, 8, 12, 24 [hours post-last dose] (

    Safety

  • Sickness behavior assessment

    Part A: 0, 2, 4, 6, 8, 10, 12 [hours post-dose] / Part B: 0, 1, 2, 4, 6, 12 [hours post-dose], as well as 24, 48, 72 [hours post-last dose] (Day 7)

    Mood and sleep

  • Electrocardiogram (ECG) as a measure of safety and tolerability

    Screening and 0, 3 [hours post-dose]

    Safety

Who could take part

Relapsing MS · 18 to 45

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      May 2006

    2. Main results due

      Jul 2006

    3. Finished

      Jul 2006

    Assembled by software from public sources.