A PET Study of ENX-104 in Healthy Volunteers

Engrail Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: ENX-104

Study type

Interventional

Funder types

Industry

Identifiers

NCT07253272

ENX-104-002

Details and patient eligibility

About

The study is designed to evaluate the D2/D3 receptor occupancy (RO), safety, tolerability, and pharmacokinetics (PK) of ENX-104 in healthy volunteers.

Enrollment

10 patients

Sex

All

Ages

23 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Biologically female participants (defined as assigned female at birth)
1. Of non-childbearing potential, defined as either permanently sterilized or postmenopausal and with a negative pregnancy test
2. Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct
Biologically male participants (defined as assigned male at birth), if fertile must be willing to use a condom or remain abstinent. Participants assigned male at birth should use a highly effective method of birth control and refrain from sexual activity with partners of childbearing potential who do not use a highly effective method of birth control during the study. Participants assigned male at birth who are not surgically sterilized for at least 90 days prior to Screening and are sexually active with partner(s) of childbearing potential, must agree to 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.