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

NCT07442149 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: A-005-001
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 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)

  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

• 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)

  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)

  17 days

Other Outcomes (1)

• To assess A-005 penetration in the CSF

  4 days

Study Arms (3)

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

Interventions

A-005 DRUG

Single oral dose of A-005

Part A: Single Ascending Dose (SAD); Part C: Lumbar Puncture

Placebo DRUG

A-005 matched placebo

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Jorn Drappa, Medical Director

  Alumis Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: April 22, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)