CompletedNCT07442149Updated Mar 2, 2026

An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005

A Phase 1 interventional study of A-005 and A-005 in Healthy Volunteer, sponsored by Alumis Inc. Completed at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Alumis Inc · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Dec 2024, 1 year 9 months ago, and no results have been posted to the registry.
Registered 1 year 10 months after the study started (first participant enrolled Apr 2024, registered Feb 2026).

Phase: Phase 1
Study type: Interventional
Enrollment: 135
Allocation: Randomized
Ages: 19 Years to 55 Years
Sex: All

Study summary

This is a 3-part study. Parts A and B are randomized, double-blind, placebo-controlled, multi-cohort investigations to assess the safety, PK, and PD of single ascending doses (SAD; Part A) and multiple ascending doses (MAD; Part B) of orally-administered A-005. Part C is optional and will be an open-label, one-cohort, single dose study to assess the penetration of orally-administered A-005 into the CSF (Cerebrospinal fluid).

Read the detailed description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Conditions studied

Healthy Volunteer

In context

Lead sponsor

Alumis Inc is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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, and vital signs
No ECG findings of clinical significance
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion criteria

Exclusion Criteria:

History or evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery.
Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
Creatinine phosphokinase levels > ULN at the screening visit.
Clinically significant laboratory abnormalities in white blood cell count, absolute neutrophil count, or absolute lymphocyte count at the screening visit.
Triglyceride levels > ULN at the screening visit.
Clinically significant abnormalities on urinalysis at the screening visit.
Any history of malignant disease excluding surgically resected skin squamous cell or basal cell carcinoma.
Presence of clinically relevant immunosuppression from immunodeficiency conditions such as common variable hypogammaglobulinemia.
Presence or evidence of recent sunburn, scar tissue, tattoo (more than 25% of body area), open sore, or branding that, in the opinion of the PI or designee, would interfere with interpretation of skin adverse reaction assessments, and, for Part C only, with the lumbar puncture.
Positive test results for active human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb), or hepatitis C virus (HCV) antibodies at the screening visit.
Any positive responses within the past 12 months and in the opinion of the PI or designee on the C-SSRS at the screening visit or at first check-in (Day -1).
Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Exception: cholecystectomy is allowed.
Use of any vaccinations, other than the COVID-19 vaccination, within 30 days prior to the first dosing. For the COVID-19 vaccination, the first or second vaccination must be received at least 15 days prior to the dosing.
Participation in another investigational clinical trial within 30 days (or 5 half-lives of the investigational agent) (whichever is longer) for small molecules and within 60 days for biologic compounds (or for the anticipated duration of the biologic compound's PD effects, whichever is longer), prior to the first dosing.
Any other condition or prior therapy that in the opinion of the PI or designee would make the subject unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
For Part C only: Subjects with bleeding disorders, relevant lab abnormalities (Screening international normalized ratio greater than 1.4, platelets less than 50), prior intolerance of lumbar puncture, anatomical reasons preventing safe or successful collection of fluid (skin infection at site of puncture, relevant spine surgery, spinal deformity, etc.), known intracranial space-occupying lesions with mass effect, posterior fossa masses, or relevant brain malformations (Arnold-Chiari malformation, etc.), exam findings suggestive of increased intracranial pressure, or known allergy/sensitivity to lidocaine or its derivatives will not be eligible.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 135 participants (actual)

Study arms

Experimental
Part A: Single Ascending Dose (SAD)
Drug: A-005 · Drug: Placebo
Experimental
Part B: Multiple Ascending Dose (MAD)
Drug: A-005 · Drug: Placebo
Experimental
Part C: Lumbar Puncture
Drug: A-005

Interventions

DrugA-005
Single oral dose of A-005
DrugA-005
Multiple doses of A-005
DrugPlacebo
A-005 matched placebo

What researchers measure

Primary outcomes

Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE in single oral dose administration of A-005 in healthy adult subjects.
Time frame: 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
Time frame: 17 days

Secondary outcomes

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)
Time frame: 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)
Time frame: 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)
Time frame: 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 terminal elimination half-life (t1/2)
Time frame: 4 days
To assess the pharmacokinetics (PK) parameters of A-005 in plasma following multiple oral dose administration of A-005 in healthy subjects via area under the concentration time curve (AUC)
Time frame: 17 days
To assess the pharmacokinetics (PK) parameters of A-005 in plasma following multiple oral dose administration of A-005 in healthy subjects via time of maximum plasma concentration (Tmax)
Time frame: 17 days
To assess the pharmacokinetics (PK) parameters of A-005 in plasma following multiple oral dose administration of A-005 in healthy subjects via maximum plasma concentration (Cmax)
Time frame: 17 days
To assess the pharmacokinetics (PK) parameters of A-005 in plasma following multiple oral dose administration of A-005 in healthy subjects via terminal elimination half-life (t1/2)
Time frame: 14 days
To assess the pharmacokinetics (PK) parameters of A-005 in urine following single oral dose administration of A-005 in healthy subjects via cumulative amounts of unchanged A-005
Time frame: 4 days
Change from baseline in ECG parameter ΔQTc interval in Part A: SAD
Time frame: 24 hours
Change from baseline in ECG parameter ΔQTc interval in Part B: MAD
Time frame: 48 hours
Assess the PK parameters of A-005 via area under the concentration time curve (AUC)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples.
Time frame: 4 days
Assess the PK parameters of A-005 via time of maximum plasma concentration (Tmax)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples.
Time frame: 4 days
Assess the PK parameters of A-005 via the maximum plasma concentration (Cmax)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples.
Time frame: 4 days

Other outcomes

To assess A-005 penetration in the CSF
Measurement of A-005 in the CSF
Time frame: 4 days

Study locations

1 site

Celerion
Lincoln, Nebraska 68502, United States

References and documents

Individual participant data

Plan to share: Undecided — The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07442149
Lead sponsor: Alumis Inc
Responsible party: Sponsor
First posted: Mar 2, 2026
Start date: Apr 22, 2024
Primary completion: Dec 18, 2024
Completion: Dec 18, 2024
Last update: Mar 2, 2026

Study contacts

Jorn Drappa, Medical Director

study director · Alumis Inc

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Alumis Inc

Start the discussion