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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Alumis Inc
Study ID
NCT07442149
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • A-005 — DRUG
    Single oral dose of A-005
  • A-005 — DRUG
    Multiple doses of A-005
  • Placebo — DRUG
    A-005 matched placebo

Study Details

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).

Key Dates

Start date
Apr 22, 2024
Status verified
Feb 2026
Primary completion
Dec 18, 2024
Completion
Dec 18, 2024

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Single Ascending Dose (SAD)
  • Experimental: Part B: Multiple Ascending Dose (MAD)
  • Experimental: Part C: Lumbar Puncture

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionLincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion· Lincoln, NE

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