An open label study to assess the safety and tolerability of PB006 administered as a single intravenous infusio

Completed

• Conditions: Multiple Sclerosis; 10029317

• Registration Number: NL-OMON48246
• Lead Sponsor: bioeq GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-11-07
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- safety<br /><br>- tolerability</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>