Recent Updates
Recently added Catalysts

HIB210

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05928585A Study of Safety and Drug Levels of HIB210 in Healthy VolunteersPHASE1 COMPLETED 30Jul 6, 2023Jun 10, 2024Feb 7, 20251 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range19 Years — 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
Unlock Eligibility Criteria