A Phase I, Randomized, Double-Blind, Parallel Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Two Formulations of MSB11022 (Proposed Adalimumab Biosimilar)<br> - EMR200588-003

Merck0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

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试验速览

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•Healthy male and female subjects, 18 to 55 years of age, who are on adequate contraception and are willing and able to comply with the scheduled study visits, investigational medicinal product administration, laboratory tests, and all other study procedures will be eligible for participation in the study.
•Other protocol-defined inclusion criteria could apply.

•- A history and/or current presence of clinically significant atopic allergy, hypersensitivity or allergic reactions
•- Having active or latent tuberculosis or a history of tuberculosis
•- Having a lifetime history of invasive systemic fungal infections or other opportunistic infections, chronic or recurrent infections
•- Having previously been treated with adalimumab or taken a recombinant monoclonal antibody, or having received a live vaccine within 12 weeks before enrolling in this study or planning for any such
•vaccination during the study or within 4 months after study drug administration.
•Other protocol-defined exclusion criteria could apply

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