Healthy VolunteerPhase 1NCT07442149
An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005
A Phase 1 study testing A-005 in people with Healthy Volunteer, run by Alumis Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- A-005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 18 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of A-005 in Healthy Adult Subjects
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
- Healthy Volunteer
- Being tested
- A-005, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-005Drug
Single oral dose of A-005
A-005Drug
Multiple doses of A-005
PlaceboDrug
A-005 matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Not described Receives: Drug: A-005; Drug: Placebo |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Not described Receives: Drug: A-005; Drug: Placebo |
| Part C: Lumbar Puncture | Experimental | Not described Receives: Drug: A-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE in single oral dose administration of A-005 in healthy adult subjects.
Measured: 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
Measured: 17 days
Secondary outcomes (14)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 4 days
Change from baseline in ECG parameter ΔQTc interval in Part A: SAD
Measured: 24 hours
Change from baseline in ECG parameter ΔQTc interval in Part B: MAD
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start22 Apr 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alumis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorn Drappa, Medical Director, Study director, Alumis Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442149
- Sponsor's protocol ID
- A-005-001
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of A-005 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07442149
- Acronym / sponsor ID
- A-005-001
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Alumis IncIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Drug: A-005, Drug: Placebo |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Drug: A-005, Drug: Placebo |
| Part C: Lumbar Puncture | Experimental | Drug: A-005 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-005Single oral dose of A-005 | Drug | Part A: Single Ascending Dose (SAD), Part C: Lumbar Puncture |
| A-005Multiple doses of A-005 | Drug | Part B: Multiple Ascending Dose (MAD) |
| PlaceboA-005 matched placebo | Drug | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD) |
Primary outcome
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
14 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)
Time frame: 4 days
Assess the PK parameters of A-005 via time of maximum plasma concentration (Tmax)
Time frame: 4 days
Assess the PK parameters of A-005 via the maximum plasma concentration (Cmax)
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided. The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorn Drappa, Medical Director study director
Alumis Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A-005 in people with Healthy Volunteer, run by Alumis Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.