NCT07253324CompletedPhase 1
ENX-104 MAD Study for Participants With Major Depressive Disorder With Anhedonia (aMDD)
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-104 in Participants With Major Depressive Disorder With Anhedonia
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 19 Nov 2025
- Start date
- 17 Feb 2025
- Primary completion date
- 26 Nov 2025
- Lead sponsor
- Engrail Therapeutics INC
- Diseases
- Depression
- NCT number
- NCT07253324
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 48
- From 17 Feb 2025 to the primary completion date, 26 Nov 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MAC Clinical Research Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| MAC Clinical Research Coordinator of this site? Confirm its status | Cannock | United Kingdom | Unknown status |
| MAC Clinical Research Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| MAC Clinical Research Coordinator of this site? Confirm its status | Prescot | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.