ENX-104 MAD Study for Participants With Major Depressive Disorder With Anhedonia (aMDD)

NCT07253324 | Completed Phase 1 DMC

• 1 other identifier: ENX-104-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ENX-104 in participants with major depressive disorder with anhedonia (aMDD).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAE)

  From Day 1 up to Day 21

Study Arms (2)

ENX-104

EXPERIMENTAL

Drug: ENX-104

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ENX-104 DRUG

Oral Solution

ENX-104

Placebo DRUG

Oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biologically female participants (defined as assigned female at birth)
• Of non-childbearing potential, defined as either permanently sterilized or postmenopausal and with a negative pregnancy test.
• Of childbearing potential and willing to use both a highly effective method of contraception and a condom with any partner or remain abstinent, and with a negative pregnancy test
• Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct
• Biologically male participants (defined as assigned male at birth), if fertile must be willing to have a partner use a highly effective method of contraception and participant use a condom with any partner of childbearing potential, or remain abstinent

You may not qualify if:

• Unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study.

Sponsors & Collaborators

• Engrail Therapeutics INC: lead

Study Sites (4)

MAC Clinical Research

Blackpool, Lancashire, FY2 0JH, United Kingdom

Location

MAC Clinical Research

Prescot, Merseyside, L341BH, United Kingdom

Location

MAC Clinical Research

Cannock, South Staffordshire, WS11 0BN, United Kingdom

Location

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: February 17, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)