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Completed

NCT Number: NCT07253246

ENX-205 SAD/PET Study in Healthy Adults

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).

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel London EPCU

London, Middlesex, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

ENX-205

Drug

oral solution

Placebo

Drug

oral solution

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

Sponsors and collaborators

Lead sponsor

Engrail Therapeutics INC

Industry

Registry information

Official study title

A Two-Part, Single Ascending Dose and Positron Emission Tomography Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Receptor Occupancy After Single Oral Dose Administration of ENX-205 in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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