A single dose, randomised, double-blind parallel group study to compare the pharmacokinetics and pharmacodynamics of PB006 with Tysabri® in healthy subjects
- Conditions
- Multiple Sclerosis MS10003816
- Registration Number
- NL-OMON49168
- Lead Sponsor
- Polpharma Biologics S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 149
1. The subject is male/female and 18 to 54 years of age, inclusive
2. The subject is healthy as determined by their medical history, a physical
examination, vital signs, an ECG and clinical laboratory testing
3. The subject has a BMI within the range of 18.5 to 30.0 kg/m2, inclusive and
a body weight of 50 - 92 kg, inclusive
4. The subject provided written, informed consent prior to any clinical
study-specific procedures.
5. Male subject (if his female spouse/partner is of childbearing potential)
must confirm that he is using two acceptable methods for contraception during
the study and for 3 months after final study drug administration. Male subject
should confirm he has informed his partner of participation in the study and
the need to avoid pregnancy. Surgically sterilised male subjects do not require
additional use of contraception.
Subject needs, after implementation of amendment 3, 2 negative PCR SARS-CoV-2
tests before dosing with natalizumab (after admission to the clinic and prior
to dosing).
Further criteria apply
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
3. Known or suspected hypersensitivity to natalizumab, or any components of the
formulation used
4. Any exposure to steroids prior to dosing, to agents such as interferon-β,
glatiramer acetate, fingolimod or laquinimod, to teriflunomide or to dimethyl
fumarate
5. Plasma exchange within 3 weeks prior to dosing.
Exclusion of subjects with a history or evidence of SARS-CoV-2 infection in the
last month prior screening 1 or having been in confirmed contact with
SARS-CoV-2 positive subjects in the last 2 weeks before dosing (after
implementation of amendment 3).
Further criteria apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• To demonstrate pharmacokinetic comparability of PB006 to US-licensed Tysabri®<br /><br>in terms of AUC0-inf of total natalizumab<br /><br>• To demonstrate pharmacokinetic comparability of PB006 to EU-approved Tysabri®<br /><br>in terms of AUC0-inf of total natalizumab<br /><br>• To demonstrate comparability pharmacokinetics of US-licensed and EU-approved<br /><br>Tysabri® in terms of AUC0-inf of total natalizumab<br /><br>• To demonstrate pharmacodynamic comparability of PB006 to pooled reference<br /><br>(US-licensed Tysabri® and EU-approved Tysabri®) in terms of baseline-adjusted<br /><br>AUEC0-12w of CD19+<br /><br>• To demonstrate pharmacodynamic comparability of PB006 to US-licensed Tysabri®<br /><br>and EU-approved Tysabri® in terms of parameters of a4-integrin receptor<br /><br>saturation</p><br>
- Secondary Outcome Measures
Name Time Method