A Study of ENX-104 in Healthy Participants

A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics, 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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment 1	Drug: ENX-104; Oral solution; Drug: ENX-104; Tablets
Experimental: Treatment 2	Drug: ENX-104; Oral solution; Drug: ENX-104; Tablets
Experimental: Treatment 3	Drug: ENX-104; Oral solution; Drug: ENX-104; Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma Concentration of ENX-104	Up to Day 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Up to Day 22
Plasma Concentration of Metabolites of ENX-1014	Up to Day 16

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 25, 2026
• Primary Completion (Actual): March 19, 2026
• Study Completion (Actual): March 19, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ENX-104-004

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
• product manufactured in and exported from the U.S.: No