Safety, Blood Levels and Effects of AUT00201

Autifony Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Placebo

Drug: AUT00201

Study type

Interventional

Funder types

Industry

Identifiers

NCT04158453

AUT011201

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers
Must have body mass index (BMI) of 18.0-31.0 kg/m2
Must be healthy based on clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
Must be 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
Use of over-the-counter medication within previous 7 days (with the exception of Paracetamol [acetaminophen])
Prescribed medication during previous 28 days
Participation in other clinical trials of unlicensed medicines
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