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A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJA001 in Fasting and Fed Healthy Participants

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Trial Profile

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJA001 in Fasting and Fed Healthy Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Mar 2025

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At a glance

  • Drugs AJA 001 (Primary)
  • Indications Mental disorders; Neurological disorders
  • Focus Adverse reactions; First in man
  • Sponsors AJNA Australia

Most Recent Events

  • 24 Feb 2025 According to a Charlottes Web Holdings media release, company announced that the U.S. Food and Drug Administration (FDA) has completed its review of Phase 1 data and Investigational New Drug (IND) application submitted by DeFloria, Inc.
  • 12 Dec 2024 According to a DeFloria media release, The safety, PK, and PD findings from phase 1 study support doses from 100 mg to 660 mg of AJA001 per day for Phase 2 trials in children, adolescents, and adults with ASD.
  • 12 Dec 2024 Results presented in the DeFloria Media Release.

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