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BIIB023- low dose Dose

Phase 1

Healthy Volunteers | Small molecule | Other |Biogen Inc.|Last Updated: Sep 16, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

BIIB023- low dose Dose · 1 trial · 1 indication

Phase 1 1
NCT01407406Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy VolunteersHealthy Volunteers
COMPLETED48 Analytics
PHASE1COMPLETED
Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC of BIIB023
Participants will be followed for the duration of a study; an expected 71 days
Cmax of BIIB023
Participants will be followed for the duration of a study; an expected 71 days
Tmax of BIIIB023
Participants will be followed for the duration of a study; an expected 71 days
Half-life of BIIB023
Participants will be followed for the duration of a study; an expected 71 days
Volume of distribution of BIIB023
Participants will be followed for the duration of a study; an expected 71 days
Clearance of BIIB023
Participants will be followed for the duration of a study; an expected 71 days

Secondary Endpoints

Number of patients with Adverse Events as a measure of safety and tolerability
Participants will be followed for the duration of a study; an expected 71 days
Number of patients with Serious Adverse Events as a measure of safety and tolerability
Participants will be followed for the duration of a study; an expected 71 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Chinese Subjects - low dose BIIB023 IVEXPERIMENTAL -
Chinese Subjects - high dose BIIB023 IVEXPERIMENTAL -
Japanese Subjects - low dose BIIB023 IVEXPERIMENTAL -
Japanese Subjects - high dose BIIB023 IVEXPERIMENTAL -
Causasian Subjects - low dose BIIB023 IVEXPERIMENTAL -
Caucasian Subjects - high dose BIIB023 IVEXPERIMENTAL -

Interventions

NameTypeDescription
BIIB023 - low dose IV DoseDRUG -
BIIB023 - high dose IV DoseDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Must have the ability to understand the purpose and risks of the study \& provide signed \& dated informed consent. * Chinese, Japanese or Caucasian subjects * Subjects of childbearing potential must practice effective contraception during the study and 3 months after their la...

Countries:AustraliaChina
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Frequently asked questions about BIIB023- low dose Dose

What is BIIB023 used for?

BIIB023 is an investigational monoclonal antibody being studied for use in rheumatoid arthritis and in healthy volunteers. It has been evaluated in Phase 1 clinical trials for these conditions, though it is not approved and remains in clinical development.

What does BIIB023 target?

BIIB023 is an anti-TWEAK monoclonal antibody, meaning it targets the cytokine TWEAK. It was studied in a Phase 1 trial in subjects with rheumatoid arthritis to assess its effects, though no efficacy data from that trial is available here.

Who makes BIIB023?

BIIB023 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen has sponsored the clinical trials of BIIB023 in rheumatoid arthritis and healthy volunteer studies.

What phase is BIIB023 in?

BIIB023 is in Phase 1 clinical development. All three completed trials of BIIB023 were Phase 1 studies, including trials in rheumatoid arthritis and healthy volunteers. It is investigational and has not been approved by regulatory authorities.

What clinical trials is BIIB023 in?

BIIB023 has been studied in three completed Phase 1 trials: NCT00771329 in rheumatoid arthritis, NCT01407406 in healthy volunteers of different ethnicities, and NCT01943513 in healthy male volunteers for muscle atrophy. All trials are completed.

Is BIIB023 the same as anti-TWEAK?

BIIB023 is an anti-TWEAK monoclonal antibody, and the trial NCT00771329 is titled 'BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis.' This indicates BIIB023 is the drug being evaluated as an anti-TWEAK agent in that study.