A PET Study of ENX-104 in Healthy Volunteers

NCT07253272 | Completed Phase 1 DMC

• 1 other identifier: ENX-104-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAE)

  From Day 1 up to Day 9

Study Arms (1)

ENX-104

EXPERIMENTAL

Drug: ENX-104

Interventions

ENX-104 DRUG

Oral solution

ENX-104

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Engrail Therapeutics INC: lead

Study Sites (1)

Parexel London EPCU

London, Middlesex, HA1 3UJ, United Kingdom

Location

Study Officials

• David George Steel, MBChB

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: February 24, 2025
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)