Multiple Ascending Dose, ENX-104 in MDD with Anhedonia
Research type
Research Study
Full title
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-104 in Participants with Major Depressive Disorder with Anhedonia
IRAS ID
1011099
Contact name
Eve Taylor
Contact email
Sponsor organisation
Engrail Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
This is a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study to evaluate the safety, tolerability, PK, and PD of ENX-104 in participants with aMDD.\nTwo (2) groups of participants will be enrolled:\n• Group A (Monotherapy) will include participants who are not taking any concomitant medications for the treatment of aMDD\n• Group B (Adjunctive) will include participants who are taking one stable, standard-of-care (SOC) selective serotonin reuptake inhibitor (SSRI) for the treatment of aMDD. Participants will be screened at 1 of 4 enrolling clinical sites within 28 days of Day 1. All eligible participants will be admitted to 1 central Clinical Research Unit (CRU) on Day -1 and are expected to remain confined for 16 days; discharge will be contingent upon clinical assessment and judgment of the Investigator. The 16-day Inpatient Period will include the Day of Admission (Day -1), a 14-day Treatment Period (Day 1 through Day 14), and the Day of Discharge (Day 15). Participants are expected to return to the enrolling clinic on Day 21 for a Follow-up Visit. Throughout the study, adverse events (AEs) and concomitant medications will be assessed on all study days. A maximum of 42 evaluable participants ages 18 to 65 years (inclusive) will be enrolled. The Sponsor of this trial is Engrail Therapeutics, Inc.
REC name
Wales REC 1
REC reference
24/WA/0337
Date of REC Opinion
21 Jan 2025
REC opinion
Further Information Favourable Opinion