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Published on 01 January 2025

Available IPD datapackage for study 'A Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple Sclerosis'

View Dataset
Biogen

Description

The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS. Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101).

Citations (0)

Mentions (0)

Metrics

Dataset Index

0.7

FAIR Score

31%

Citations

0

Mentions

0

Metrics Over Time

Publication Details

DOI

Publisher

Vivli

Assigned Domain

Subfield

Pharmacology

Field

Medicine

Domain

Health Sciences

Confidence Score

48%

Source

Scholar Data Model

Keywords

Conditions: Relapsing-Remitting Multiple SclerosisConditions: Multiple SclerosisInterventions: BIIB033Interventions: Placebo

Normalization Factors

FT

15.38

CTw

1.00

MTw

1.00