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

NCT07442149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-03-02

No results posted yet for this 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).

Conditions

  • Healthy Volunteer

Interventions

DRUG

A-005

Single oral dose of A-005

DRUG

A-005

Multiple doses of A-005

DRUG

Placebo

A-005 matched placebo

Sponsors & Collaborators

  • Alumis Inc

    lead INDUSTRY

Principal Investigators

  • Jorn Drappa, Medical Director · Alumis Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2024-12-18
Completion
2024-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07442149 on ClinicalTrials.gov