This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD.

Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.

Inclusion Criteria:

• Meets the DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.
• Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.
• Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
• Free from any other clinically significant illness or disease.

Exclusion Criteria:

• Primary diagnosis of any other DSM-5 disorder.
• Body mass index (BMI) <18 kg/m2 or ≥40 kg/m2.
• Unable to refrain from nicotine use for at least 8 hours.
• Use of prohibited concomitant medications or therapies.
• Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.

Sponsor