A randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of three formulations of adalimumab (M923, US Sourced Humira and EU Sourced Humira) in healthy subjects

Baxter Innovations GmbH0 个研究点目标入组 324 人开始时间: 2015年2月16日最近更新: 2020年9月14日

适应症

试验速览

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•1. Male or females of non-childbearing potential aged 18 to 55 years, inclusive
•2. Healthy as determined by pre study medical history, physical examination, vital signs and 12-lead ECG
•3. Clinical laboratory test results that are not clinically significant and are acceptable to the investigator at screening and admission to the clinical unit (Day -1)
•4. Body weight between 60.0 and 100.0 kg and a body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
•5. Male subjects must have been vasectomized with confirmation of sterility or be willing to comply with the contraception restrictions for this study
•6. Female subjects must have a negative pregnancy test at screening and on admission to the clinical unit (Day -1), must not be lactating, and must be of non-childbearing potential
•7. Has smoked =10 cigarettes or 3 cigars or 3 pipes/day for at least 3 months prior to screening and is willing to comply with smoking restrictions during confinement at the study center
•8. Willing and able to comply with the requirements of the study
•9. Willing and able to sign a written informed consent

•1. Clinically significant allergic or hypersensitivity conditions
•2. Tuberculosis, invasive systemic fungal infections, other severe opportunistic infections, recent serious infection, recent or recurrent herpes zoster infection, chronic or recurrent infections
•3. Recent or planned other investigational trial participation
•4. Alcohol abuse or drug abuse
•5. Recent use of any prescribed or non prescribed medication other than paracetamol, vitamins and for females, hormone replacement therapy
•6. Congestive heart failure
•7. Signs or symptoms of demyelinating disease
•9. Impaired liver function
•10. Immunodeficiency or other clinically significant immunological disorders
•11. Anti-citrullinated protein antibodies at screening
•12. Anti-drug antibodies to adalimumab at screening
•13. Clinically relevant history or presence of medical disorders as judged by the investigator
•14. Recent or planned receipt during the study of a live vaccine
•15. Medical dietary restrictions
•16. Subjects who cannot communicate reliably

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