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ALIA-1758

Phase 1

Alzheimer Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jul 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06406348A Phase 1 Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy ParticipantsPHASE1 COMPLETED 53May 9, 2024Apr 22, 2025Jul 17, 20251 United States
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Up to 85 days after dosing

Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)

Secondary Endpoints
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax
0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2
0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC
0-85 days after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALSingle Ascending Dose (SAD) cohorts
PlaceboPLACEBO_COMPARATORSingle Ascending Dose (SAD) cohorts
Interventions
NameTypeDescription
ALIA-1758DRUGIntravenous or subcutaneous doses
PlaceboOTHERIntravenous or subcutaneous doses
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Participants must understand the nature of the trial and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any trial-related procedures. * Healthy as determined by the Investigator, based on a medical evaluati...

Countries:United States
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