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

December 24, 2025 updated by: Engrail Therapeutics INC

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-104 in Participants With Major Depressive Disorder With Anhedonia

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY2 0JH
        • MAC Clinical Research
    • Merseyside
      • Prescot, Merseyside, United Kingdom, L341BH
        • MAC Clinical Research
    • South Staffordshire
      • Cannock, South Staffordshire, United Kingdom, WS11 0BN
        • MAC Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biologically female participants (defined as assigned female at birth)

    1. Of non-childbearing potential, defined as either permanently sterilized or postmenopausal and with a negative pregnancy test.
    2. 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
    3. 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral solution
Experimental: ENX-104
Drug: ENX-104
Oral Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Time Frame: From Day 1 up to Day 21
From Day 1 up to Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Engrail Therapeutics INC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Actual)

November 26, 2025

Study Completion (Actual)

November 26, 2025

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENX-104-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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