Safety, Blood Levels and Effects of AUT00201

Overview

The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines.

In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women.

This study will be in 2 parts, as follows:

Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men.

A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.

Full Title of Study: “A Randomised, Double-blind, Placebo-controlled, Single and Repeated Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AUT00201 in Healthy Male and Female Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2020

Interventions

  • Drug: AUT00201
    • Oral dose of AUT00201
  • Drug: Placebo
    • Oral dose of placebo

Arms, Groups and Cohorts

  • Active Comparator: AUT00201
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Percent of subjects with treatment-related adverse events
    • Time Frame: Study Duration (2 weeks post last dose)

Participating in This Clinical Trial

Inclusion Criteria

  • Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers, with a body mass index (BMI) of 18.0-31.0 kg/m2; deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine; able to give fully informed written consent.

Exclusion Criteria

  • History or presence of epilepsy, severe head injury, or any other chronic neurological condition or any psychiatric disorder; abnormal screening EEG (Part A1 and Part B only); positive tests for hepatitis B & C, HIV; severe adverse reaction to any drug; sensitivity to trial medication; drug or alcohol abuse; over-the-counter medication within previous 7 days (with the exception of paracetamol [acetaminophen]), or prescribed medication during previous 28 days; participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months; vital signs or QTcF interval outside the acceptable range; clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive result for suicidal ideation or behaviour using the Colombia suicide severity rating scale (C-SSRS ); possibility that volunteer will not cooperate; pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Autifony Therapeutics Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Alice Sharman, +44 1438 906860, alice.sharman@autifony.com

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