Single-dose ENX-205 with PET scans in healthy adults
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
This study will test single doses of ENX-205 versus placebo and use PET scans to measure brain receptor binding in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Engrail Therapeutics INC Industry-sponsored |
| Locations | 1 site (London, Middlesex) |
| Trial ID | NCT07253246 on ClinicalTrials.gov |
What this trial studies
This two-part Phase 1 study in healthy adults includes a double-blind, placebo-controlled single ascending dose (SAD) portion and an open-label PET imaging portion. Part 1 will escalate single doses of ENX-205 versus placebo to characterize safety, tolerability, pharmacokinetics, and preliminary receptor occupancy. Part 2 will administer a single dose and use positron emission tomography to directly measure receptor occupancy in the brain. The trial enrolls biologically female participants who are non-pregnant and biologically male participants who agree to contraception and other study requirements, with in-person dosing and imaging at a single UK clinical site.
Who should consider this trial
Good fit: Healthy adults who meet study criteria—non-pregnant biologically female participants (including those of non-childbearing potential) and biologically male participants willing to follow birth-control restrictions—are ideal candidates.
Not a fit: People with active medical conditions, pregnant or breastfeeding individuals, or anyone seeking direct therapeutic benefit are unlikely to gain clinical benefit from participation.
Why it matters
Potential benefit: If successful, results could help select safe doses and confirm that ENX-205 engages its brain target, speeding development toward treatments for patients who may benefit.
How similar studies have performed: Similar Phase 1 SAD and PET studies have commonly been used to measure pharmacokinetics and receptor occupancy for CNS drug candidates and have often succeeded in informing dose selection, though they do not demonstrate clinical efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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: • 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
Where this trial is running
London, Middlesex
- Parexel London EPCU — London, Middlesex, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David George Steel, MBChB — Parexel
- Study coordinator: Eve M Taylor, PHD
- Email: eve.taylor@engrail.com
- Phone: 18583425478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.