DT-101 in Adults with Major Depressive Disorder

Prior treatment

• Receipt of any investigational product within 24 weeks prior to Screening.
• Use of St John’s wort is prohibited within 14 days before administration of the first dose of investigational product on Day 1 (Baseline) until last dose of study medication.
• Blood donation or draw in excess of 400 mL within 2 months prior to Screening or plasma donation in excess of 50 mL within 30 days prior to Screening and through the duration of the study. Please refer to the study protocol for full list of exclusion criteria.

Other

• In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

• The participant is able to understand and willing to provide written informed consent.
• Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 65 years of age, inclusive at the time of signing the informed consent.
• Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022). The current episode needs to be at least 6 weeks in duration prior to the screening visit.