Safety, Blood Levels and Effects of AUT00201
|ClinicalTrials.gov Identifier: NCT04158453|
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer||Drug: AUT00201 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
|Active Comparator: AUT00201||
Oral dose of AUT00201
|Placebo Comparator: Placebo||
Oral dose of placebo
- Percent of subjects with treatment-related adverse events [ Time Frame: Study Duration (2 weeks post last dose) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158453
|Contact: HMR Recruitment Teamfirstname.lastname@example.org|
|Hammersmith Medicines Research||Recruiting|
|London, United Kingdom, NW10 7EW|
|Contact: HMR Recruitment Team|