Healthy Volunteer
Conditions
Brief 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).
Interventions
DRUGENX-205
oral solution
DRUGPlacebo
oral solution
Sponsors
Engrail Therapeutics INC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Part 2 of this study is open-label, and as such, randomization and blinding are not applicable.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of Participants with Treatment Emergent Adverse events | From Day 1 up to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: Number of Participants with Treatment Emergent Adverse events | From Day 1 up to Day 10 |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORDavid George Steel, MBChB
Parexel
Outcome results
None listed