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

Engrail Therapeutics

Status and phase: Completed; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: ENX-104

Study type: Interventional

Funder types: Industry

Identifiers

NCT07253324

ENX-104-003

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

ENX-104

Experimental group

Treatment:

Drug: ENX-104

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo