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CompletedNCT07253246Updated May 28, 2026

ENX-205 SAD/PET Study in Healthy Adults

A Phase 1 interventional study of ENX-205 and Placebo in Healthy Volunteer, sponsored by Engrail Therapeutics INC. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Engrail Therapeutics INC · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2025, registered Nov 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Engrail Therapeutics INC is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Biologically female participants who are not pregnant, lactating, or breastfeeding

    1. Of non-childbearing potential, defined as either permanently sterilized, and with a negative pregnancy test. OR
    2. 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.

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    ENX-205

    Drug: ENX-205

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugENX-205

    oral solution

  • DrugPlacebo

    oral solution

06

What researchers measure

Primary outcomes

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

    Time frame: From Day 1 up to Day 10

Secondary outcomes

  1. Part 2: Number of Participants with Treatment Emergent Adverse events

    Time frame: From Day 1 up to Day 10

07

Study locations

1 site
  • Parexel London EPCU
    London, Middlesex HA1 3UJ, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07253246
Lead sponsor
Engrail Therapeutics INC
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Mar 23, 2025
Primary completion
May 7, 2026
Completion
May 7, 2026
Last update
May 28, 2026

Study contacts

David George Steel, MBChB
principal investigator · Parexel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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