CClinicalTrials.gg
CompletedNCT07253272Updated Nov 28, 2025

A PET Study of ENX-104 in Healthy Volunteers

A Phase 1 interventional study of ENX-104 in Healthy Volunteers, sponsored by Engrail Therapeutics INC. Completed at 1 site in United Kingdom. Open to participants aged 23 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Engrail Therapeutics INC · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2025, registered Nov 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
23 Years to 65 Years
Sex
All
01

Study summary

The study is designed to evaluate the D2/D3 receptor occupancy (RO), safety, tolerability, and pharmacokinetics (PK) of ENX-104 in healthy volunteers.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Engrail Therapeutics INC is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
23 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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. 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 use a condom or remain abstinent. Participants assigned male at birth should use a highly effective method of birth control and refrain from sexual activity with partners of childbearing potential who do not use a highly effective method of birth control during the study. Participants assigned male at birth who are not surgically sterilized for at least 90 days prior to Screening and are sexually active with partner(s) of childbearing potential, must agree to refrain from sperm donation.

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    ENX-104

    Drug: ENX-104

Interventions

  • DrugENX-104

    Oral solution

06

What researchers measure

Primary outcomes

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

    Time frame: From Day 1 up to Day 9

07

Study locations

1 site
  • Parexel London EPCU
    London, Middlesex HA1 3UJ, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07253272
Lead sponsor
Engrail Therapeutics INC
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Feb 24, 2025
Primary completion
Sep 2, 2025
Completion
Sep 2, 2025
Last update
Nov 28, 2025

Study contacts

David George Steel, MBChB
principal investigator · Parexel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion