A PET Study of ENX-104 in Healthy Volunteers

An Open-label Positron Emission Tomography (PET) Study to Demonstrate Safety, Tolerability, Receptor Occupancy, and Pharmacokinetics After a Single Oral Dose Administration of ENX-104 in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ENX-104

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • London, Middlesex, United Kingdom, HA1 3UJ
      • Parexel London EPCU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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. 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:

• 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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	From Day 1 up to Day 9

Collaborators and Investigators

• Sponsor: Engrail Therapeutics INC
• Investigators: Principal Investigator: David George Steel, MBChB, Parexel

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Actual): September 2, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ENX-104-002

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