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OpenTrials
Completed

NCT Number: NCT07253324

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

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).

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MAC Clinical Research, Blackpool, Lancashire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

ENX-104

Drug

Oral Solution

Placebo

Drug

Oral solution

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAE)

    Time frame: From Day 1 up to Day 21

Sponsors and collaborators

Lead sponsor

Engrail Therapeutics INC

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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