This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of
two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and
Caucasian healthy volunteers.
Drug: BG00012 Dose 1
Drug: BG00012 Dose 2
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Locations near you
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Full eligibility criteria for NCT01453426
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
Must give written informed consent and any authorizations required by local law
All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
History of severe allergic or anaphylactic reactions
Known history of or positive test result for Human Immunodeficiency Virus (HIV)
Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
Female subjects who are pregnant or currently breastfeeding
All locations for NCT01453426
Melbourne, Victoria, Australia
Hong Kong, Hong Kong, China
View full eligibility
Tris trial is registered with FDA with number: NCT01453426. The sponsor of the trial is Biogen and it is looking for 71 volunteers for the current phase.
Official trial title: An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
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