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A-005

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

A-005 · 1 trial · 1 indication

Phase 1 1
NCT07442149An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005Healthy Volunteer
COMPLETED135 Analytics
PHASE1COMPLETED
An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005
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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 to 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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Frequently asked questions about A-005

What is A-005 used for?

A-005 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability. The drug is not approved for any indication and remains under investigation.

Who makes A-005?

A-005 is being developed by Alumis Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ALMS. The company is conducting clinical research on this investigational small molecule.

What phase is A-005 in?

A-005 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the safety and tolerability of single and multiple ascending doses of the drug in healthy volunteers. It remains an investigational drug and is not yet approved.

What clinical trials is A-005 in?

A-005 has one completed Phase 1 clinical trial, identified as NCT07442149. This study evaluated the safety and tolerability of single and multiple ascending doses of A-005 in 135 healthy volunteers in the United States. The trial was randomized, double-blind, and controlled.

Is A-005 FDA approved?

A-005 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial in healthy volunteers has been completed, but the drug has not yet received regulatory approval for any use.