NCT07253246

Brief Summary

This is a two-part study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and receptor occupancy (RO) of ENX-205 in healthy adult participants in a double-blind placebo-controlled, single ascending dose (SAD) study (Part 1) and an open-label, single-dose, positron emission tomography (PET) study (Part 2).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

November 19, 2025

Last Update Submit

April 16, 2026

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Part 1: Number of Participants with Treatment Emergent Adverse events

    From Day 1 up to Day 10

Secondary Outcomes (1)

  • Part 2: Number of Participants with Treatment Emergent Adverse events

    From Day 1 up to Day 10

Study Arms (2)

ENX-205

EXPERIMENTAL
Drug: ENX-205

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ENX-205DRUG

oral solution

ENX-205
PlaceboDRUG

oral solution

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biologically female participants who are not pregnant, lactating, or breastfeeding
  • Of non-childbearing potential, defined as either permanently sterilized, and with a negative pregnancy test. OR
  • Part 1 only: Of childbearing potential and willing to comply with restrictions related to birth control, and with a negative pregnancy test.
  • Biologically male participants (defined as assigned male at birth), if fertile must be willing to comply with restrictions related to birth control. Moreover, male participants should 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel London EPCU

London, Middlesex, HA1 3UJ, United Kingdom

RECRUITING

Study Officials

  • David George Steel, MBChB

    Parexel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eve M Taylor, PHD

CONTACT

18583425478eve.taylor@engrail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Part 2 of this study is open-label, and as such, randomization and blinding are not applicable.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

March 23, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)