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A-005

Phase 1

Healthy Volunteer | Small molecule | Other |Alumis Inc.|Last Updated: Mar 2, 2026

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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment135
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07442149An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005PHASE1 COMPLETED 135 — — Apr 22, 2024Dec 18, 2024Mar 2, 20261 United States
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Study Endpoints
Primary Endpoints
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE in single oral dose administration of A-005 in healthy adult subjects.
4 days
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE in multiple oral dose administration of A-005 in healthy adult subjects
17 days
Secondary Endpoints
To assess the pharmacokinetics (PK) parameters of A-005 in plasma following single oral dose administration of A-005 in healthy subjects via area under the concentration time curve (AUC)
4 days
To assess the pharmacokinetics (PK) parameters of A-005 in plasma following single oral dose administration of A-005 in healthy subjects via time of maximum plasma concentration (Tmax)
4 days
To assess the pharmacokinetics (PK) parameters of A-005 in plasma following single oral dose administration of A-005 in healthy subjects via maximum plasma concentration (Cmax)
4 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Single Ascending Dose (SAD)EXPERIMENTAL -
Part B: Multiple Ascending Dose (MAD)EXPERIMENTAL -
Part C: Lumbar PunctureEXPERIMENTAL -
Interventions
NameTypeDescription
A-005DRUGSingle oral dose of A-005
PlaceboDRUGA-005 matched placebo
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, adult, male or female 19-55 years of age, inclusive, at the screening visit. * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit. * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles,...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMApr 8, 2026NCT07442149TRIAL_REMOVED: changed
MEDIUMApr 8, 2026NCT07442149TRIAL_REMOVED: changed