ENX-205 SAD/PET Study in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-23

Study Completion Date

2026-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Part 2 of this study is open-label, and as such, randomization and blinding are not applicable.

Study Groups

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ENX-205

Group Type EXPERIMENTAL

ENX-205

Intervention Type DRUG

oral solution

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral solution

Interventions

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ENX-205

oral solution

Intervention Type DRUG

Placebo

oral solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes