NCT07442149

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

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of A-005 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Alumis Inc · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
DRUG	A-005	Single oral dose of A-005
DRUG	A-005	Multiple doses of A-005
DRUG	Placebo	A-005 matched placebo

Timeline

• Start date: 2024-04-22
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study