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Recruiting Phase 1 NCT07253246

ENX-205 SAD/PET Study in Healthy Adults

Phase 1 – testing safety in a small group of people
Conditions: Healthy Volunteer

Sponsor: Engrail Therapeutics INC

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
ENX-205
DRUG
Placebo
DRUG
Locations 1
United Kingdom (1)
Parexel London EPCU
London , Middlesex
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
23.03.2025
Completion date
01.04.2026
Registry ID
NCT07253246
Source
clinicaltrials.gov
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