Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.

Autifony Therapeutics

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: AUT00206

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03164876

AUT031206

Details and patient eligibility

About

This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion Criteria:

• Male patients with a diagnosis of schizophrenia no more than 5 calendar years (before screening);
• Positive and negative symptoms assessed by PANSS;
• Medically and psychiatrically stable;
• On a stable dose of antipsychotic drugs;
• Able to give fully informed written consent and likely to comply with the requirements of the trial.

Key exclusion Criteria:

• clinically relevant, as assessed by a physician, abnormal findings at the screening assessment;
• sensitivity to excipients of the trial medication;
• current use of contraindicated drugs;
• participation in another clinical trial of unlicensed medicines within the previous 30 days;
• loss of more than 400 mL blood, within the previous 3 months; history of drug or alcohol dependence in the last year;
• significant acute or chronic illness;
• significant medical history or concurrent medical condition that warrants exclusion;
• objection by subject's physician

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Dose AUT00206 800 mg BD

Experimental group

Description:

AUT00206 800mg twice daily for 28 days

Treatment:

Drug: AUT00206

Placebo

Placebo Comparator group

Description:

Placebo to match AUT00206 twice daily for 28 days

Treatment:

Drug: Placebo