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HIB210

Phase 1

Immune System Diseases | Small molecule | Other |Biogen Inc.|Last Updated: Feb 7, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

HIB210 · 1 trial · 2 indications

Phase 1 1
NCT05928585A Study of Safety and Drug Levels of HIB210 in Healthy VolunteersImmune System Diseases
COMPLETED30 Analytics
PHASE1COMPLETED
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
Immune System Diseases
NCT0592858530
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Study Endpoints

Primary Endpoints

Number of participants with adverse events
Baseline to End of Study (Up to Day 114)
Number of participants with clinical laboratory abnormalities
Baseline to End of Study (Up to Day 114)
Number of participants with electrocardiogram (ECG) abnormalities
Baseline to End of Study (Up to Day 114)
Number of participants with physical examination abnormalities
Baseline to End of Study (Up to Day 114)
Number of participants with vital sign abnormalities
Baseline to End of Study (Up to Day 114)

Secondary Endpoints

PK Parameters: Cmax
Baseline to Day 29
PK Parameters: tmax
Baseline to Day 29
PK Parameters: AUC
Baseline to Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MAD HIB210EXPERIMENTALIncreasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format
MAD PlaceboPLACEBO_COMPARATORPlacebo will be administered for cohorts 1-4 in a multiple ascending dose format

Interventions

NameTypeDescription
HIB210DRUGExperimental monoclonal antibody
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range19 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Eligibility Criteria: * Healthy male and females between 19 to 65 years of age * Normal or not significantly abnormal laboratory tests and EKG findings during Screening * No significant medical conditions that might affect ability to participate in the study or present a safety risk * No eviden...

Countries:United States
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Frequently asked questions about HIB210

What is HIB210 used for?

HIB210 is an investigational small molecule being developed for the treatment of immune system diseases, including autoimmunity. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential to address conditions related to immune system dysfunction.

Who makes HIB210?

HIB210 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 small molecule for immune system diseases, including autoimmunity.

What phase is HIB210 in?

HIB210 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for immune system diseases.

What clinical trials is HIB210 in?

HIB210 has one completed Phase 1 clinical trial registered as NCT05928585, titled "A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers." This randomized, double-blind, placebo-controlled study enrolled 30 healthy volunteers in the United States and evaluated the safety and drug levels of HIB210.

Is HIB210 FDA approved?

No, HIB210 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for immune system diseases. The completed Phase 1 trial focused on safety and drug levels in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.