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A-005

Phase 1

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

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2026

Target and mechanism

Molecular targettyrosine kinase 2
Target classKinase
ModalitySmall molecule

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?

A-005 is an investigational small molecule drug being developed by Alumis Inc. (ticker ALMS). It is a tyrosine kinase 2 (TYK2) inhibitor that has been studied in a Phase 1 clinical trial in healthy adult volunteers. It is not approved for any indication and remains in clinical development.

What does A-005 target?

A-005 targets tyrosine kinase 2, also known as TYK2. TYK2 is a kinase enzyme, making A-005 a kinase inhibitor. By targeting TYK2, the drug is designed to modulate signaling pathways associated with this kinase. Alumis Inc. is developing A-005 as a small molecule therapeutic candidate.

Who makes A-005?

A-005 is being developed by Alumis Inc., which trades under the ticker symbol ALMS. Alumis is the sponsor of the clinical program evaluating A-005. The company is advancing the drug as an investigational small molecule candidate targeting tyrosine kinase 2.

What phase is A-005 in?

A-005 is in Phase 1 clinical development. Its single Phase 1 trial has been completed, and no active trials are currently listed. The study evaluated single and multiple ascending doses in healthy volunteers. A-005 is investigational and has not been approved by the FDA for any indication.

What clinical trials is A-005 in?

A-005 has been evaluated in one completed Phase 1 trial, NCT07442149, titled "An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005." The randomized, double-blind, controlled study enrolled 135 healthy volunteers in the United States, with participants aged 19 years and older.