SAD & PET Study to Evaluate ENX-205 in Healthy Volunteers
Research type
Research Study
Full title
A Two-Part, Single Ascending Dose and Positron Emission Tomography Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Receptor Occupancy After Single Oral Dose Administration of ENX-205 in Healthy Adult Participants
IRAS ID
1011367
Contact name
Eve Taylor
Contact email
Sponsor organisation
Engrail Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
The trial is a 2 Part trial with up to 50 healthy, non-smoking males and females assigned at birth, inclusive of any gender identity between the ages of 18 and 65 years, inclusive for Part 1 and 23 and 65 years, inclusive in Part 2\n\nThe medicine to be tested is this trial is a compound called ENX-205 being developed a new therapy for treating PTSD and other disorders of the central nervous system.\n\nThe main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after dosing of the clinical trial medicine in healthy subjects and how it is absorbed in the brain. The clinical trial will also investigate how the clinical trial medicine is taken up and metabolised (chemically broken down). \nThe trial will comprise of: \nPart 1\n-\tScreening period of a maximum 35 days – Day -35 to Day -2\n-\tIn-house Treatment Period - Day -1 to Day 3 (admission on Day -2, Dosing on Day 1)\n-\tA Follow up Visit on Day 10 (+/- 1 Day)\n\nPart 2\nScreening period of a maximum 45 days – Day -45 to Day -3\n-\tIn-house Treatment Period - Day -2 to Day 2 (admission on Day -2, Dosing on Day 1)\n-\tA Follow up Visit on Day 10 (+/- 1 Day)
REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0009
Date of REC Opinion
7 May 2025
REC opinion
Further Information Favourable Opinion