NCT07253246

ENX-205 SAD/PET Study 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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Engrail Therapeutics INC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	ENX-205	oral solution
DRUG	Placebo	oral solution

Timeline

• Start date: 2025-03-23
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-11-28
• Last updated: 2026-03-11

Locations

1 site across 1 country: United Kingdom