Multiple Sclerosis
Conditions
Interventions
The volunteer will be given 300 mg PB006 as an intravenous infusion (solution
of the compound that will be administered directly in a blood vessel),
administered over 60 minutes.
For safety reason
Sponsors
bioeq GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - healthy males and females - 18-65 years, inclusive - BMI: 18.5-32.0 kg/m2
Exclusion criteria
Exclusion criteria: 1. Any known exposure to natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab, ofatumumab or obinutuzumab or any other B- and T-cell targeting therapies. 2. Any known exposure to immunosuppressive agents (e.g. methotrexate, cyclosporine, azathioprine, mitoxantrone, tacrolimus) 3. Known or suspected hypersensitivity to natalizumab, or any components of the formulation used (L-histidine/L-histidine hydrochloride, sodium chloride, polysorbate 80). 4. Any exposure to steroids within one month prior to dosing, to agents such as interferon-β, glatiramer acetate, fingolimod laquinimod within the last 2 months, toteriflunomide during the last 3.5 months, or to dimethyl fumarate within 6 months prior to dosing. 5. Positive test for anti-JCV antibodies [screening 1]. 6. Female subject who has been pregnant within 6 months prior to screening 2, or breastfeeding or lactating within 3 months prior to screening 2. 7. Any of the liver enzymes (AST, ALT, alkaline phosphatase [ALP], gamma-glutamyltransferase [GGT]) and TBL above the ULN. In such a case the assessment may be repeated once. [Screening 2 and Day-1] 8. Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).;Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - safety - tolerability | — |
Countries
Netherlands
Outcome results
None listed