A Study of ENX-104 in Healthy Participants

NCT07472361 | Completed Phase 1

• 1 other identifier: ENX-104-004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluate the relative bioavailability, safety, and tolerability of a single dose of ENX-104 administered orally as a solution fasted, a tablet fasted, or a tablet with a high fat meal in healthy participants

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Plasma Concentration of ENX-104

  Up to Day 16

Secondary Outcomes (2)

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

  Up to Day 22

• Plasma Concentration of Metabolites of ENX-1014

  Up to Day 16

Study Arms (3)

Treatment 1

EXPERIMENTAL

Drug: ENX-104

Treatment 2

EXPERIMENTAL

Drug: ENX-104

Treatment 3

EXPERIMENTAL

Drug: ENX-104

Interventions

ENX-104 DRUG

Tablets

Treatment 1; Treatment 2; Treatment 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Biologically female participants (defined as assigned female at birth): a) Of non-childbearing potential, (Note: For female participants with Follicle-Stimulating Hormone \[FSH\] levels that are not consistent with postmenopausal status, enrollment will be at the Investigator's discretion and will require a negative pregnancy test Screening and Admission \[Day -1\]); b) Of childbearing potential and willing to use highly effective methods of contraception, from Screening until 180 days after the last exposure to study drug, and with a negative pregnancy test at Screening and Admission (Day -1); c) 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 highly effective contraception, from first Screening through to 3 months after the last dose of study drug

You may not qualify if:

• Is 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

Middlesex, London, HA1 3UJ, United Kingdom

Location

Study Officials

• David George Steel, MBChB

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 16, 2026
• Study Start: February 25, 2026
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)