A randomised, double-blind, placebo-controlled, single and repeated dose escalation study to assess the safety, tolerability, pharmacokinetics and food effect of a new formulation of AUT00206 in healthy men and women

Autifony Therapeutics (United Kingdom)0 sites41 target enrollmentSeptember 28, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Autifony Therapeutics (United Kingdom)
Enrollment: 41
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2022 Funder report results see attached file 40474 Funder report V1 04Oct2022.pdf [1] (added 14/11/2022)

Registry

who.int

Start Date

September 28, 2021

End Date

April 12, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Autifony Therapeutics (United Kingdom)

Eligibility Criteria

Inclusion Criteria

•Current participant inclusion criteria as of 21/01/2022:
•1\. Healthy male volunteer (Parts A1 and B only) or healthy female volunteer (Part A2 only).
•2\. Aged 18 \- 45 years (at \[first] dosing) (Part A and Part B Groups 1 and 2\) or aged \>18 years and targeted towards those aged \>45 years (Part B Groups 3 and 4\)
•3\. A BMI (Quetelet index) in the range 18\.0 \- 31\.0 kg/m²
•4\. Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
•5\. Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
•6\. Agree to follow the contraception requirements of the trial as described in the protocol/ICF.
•7\. Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
•8\. Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).
•Previous participant inclusion criteria:

Exclusion Criteria

•1\. Woman who is pregnant or lactating, or pre\-menopausal woman who is sexually active and not using a highly\-effective method of contraception.
•2\. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre\-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
•3\. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the trial or make it unnecessarily hazardous.
•4\. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, post\-COVID\-19 syndrome (‘long COVID’), or history of any psychotic mental illness.
•5\. Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
•6\. Presence or history of severe adverse reaction to any drug, or a history of sensitivity to AUT00206 or its excipients.
•7\. Use of a prescription medicine (except oral contraceptives in females) during the 30 days before the first dose of trial medication, or use of an over\-the\-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days before the first dose of trial medication.
•8\. Use of vaccine (including COVID\-19 vaccine) during the 7 days, before first receipt of trial medication until the end of the study.
•9\. History of epilepsy or seizures.
•10\. Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before \[first] admission to this study; in the follow\-up period of another clinical trial at the time of screening for this study.