Major Depressive Disorder
Conditions
Brief summary
The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ENX-104 in participants with major depressive disorder with anhedonia (aMDD).
Interventions
DRUGENX-104
Oral Solution
DRUGPlacebo
Oral solution
Sponsors
Engrail Therapeutics INC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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. Of childbearing potential and willing to use both a highly effective method of contraception and a condom with any partner or remain abstinent, and with a negative pregnancy test 3. 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 have a partner use a highly effective method of contraception and participant use a condom with any partner of childbearing potential, or remain abstinent
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 |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAE) | From Day 1 up to Day 21 |
Countries
United Kingdom
Outcome results
None listed