ENX-205 SAD/PET Study in Healthy Adults

Engrail Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: ENX-205

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07253246

ENX-205-001

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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