ENX-104 MAD Study for Participants With Major Depressive Disorder With Anhedonia (aMDD)

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-104 in Participants With Major Depressive Disorder With Anhedonia

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).

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.