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BIIB076

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Biogen Inc.|Last Updated: Mar 24, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

BIIB076 · 1 trial · 2 indications

Phase 1 1
NCT03056729Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's DiseaseAlzheimer's Disease
COMPLETED46 Analytics
PHASE1COMPLETED
Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to Week 20

Safety surveillance

Secondary Endpoints

BIIB076 serum pharmacokinetics (PK) concentration levels
Up to Week 20
PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)
Up to Week 20
PK parameter of BIIB076: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Up to Week 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort HV1EXPERIMENTAL -
Cohort HV2EXPERIMENTAL -
Cohort HV3EXPERIMENTAL -
Cohort HV4EXPERIMENTAL -
Cohort HV5EXPERIMENTAL -
Cohort AD1EXPERIMENTAL -

Interventions

NameTypeDescription
BIIB076DRUGAdministered as single intravenous (IV) infusion
PlaceboDRUGAdministered as single IV infusion
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites8

Key Inclusion Criteria - Healthy Participants * Must be in good health as determined by the Investigator, based on medical history and Screening evaluations. Key Inclusion Criteria - Participants with Alzheimer's Disease (AD) * Must meet all of the clinical criteria for mild cognitive impairment ...

Countries:United States
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Frequently asked questions about BIIB076

What is BIIB076 used for?

BIIB076 is an investigational small molecule being developed for Alzheimer's Disease. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities and is still being studied for safety and tolerability in clinical trials.

Who makes BIIB076?

BIIB076 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical research on this investigational therapy for Alzheimer's Disease.

What phase is BIIB076 in?

BIIB076 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The drug is being studied in early-stage clinical trials to evaluate its safety, tolerability, and pharmacokinetics in humans.

What clinical trials is BIIB076 in?

BIIB076 has one completed Phase 1 clinical trial, identified as NCT03056729. This was a single-ascending-dose study conducted in the United States, enrolling 46 participants, including healthy volunteers and individuals with Alzheimer's Disease. The trial was randomized, double-blind, and controlled.

Is BIIB076 the same as any other drug?

BIIB076 is the investigational name for this drug candidate developed by Biogen. No alternative names have been disclosed in the available information. It is a distinct small molecule being studied for Alzheimer's Disease.