A single dose, randomised, double-blind parallel group study to compare the pharmacokinetics and pharmacodynamics of PB006 with Tysabri® in healthy subjects - PB006/Tysabri bioequivalence study

Polpharma Biologics S.A.0 个研究点目标入组 149 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•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
•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
•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

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