RecruitingPhase 1NCT07253246

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

Sponsor

Engrail Therapeutics INC

Enrollment

60 participants

Start Date

Mar 23, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer

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).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria1

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

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