NL-OMON48246
Completed
Not Applicable
An open label study to assess the safety and tolerability of PB006 administered as a single intravenous infusion - PB006 single dose safety study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- bioeq GmbH
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- healthy males and females
- •\- 18\-65 years, inclusive
- •\- BMI: 18\.5\-32\.0 kg/m2
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.
Outcomes
Primary Outcomes
Not specified
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