A Phase 1 Randomized, First-in-Human, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of EMP-01 in Healthy Adult Volunteers

This randomised, double-blind, placebo-controlled trial (n=32) will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses of EMP-01 (ar-MDMA) in healthy adult volunteers.

EMP-01 is being developed as a potential treatment for post-traumatic stress disorder (PTSD). The study will consist of 4 cohorts, each with 8 participants, who will receive different doses of EMP-01 or placebo. Safety and tolerability will be assessed through adverse events monitoring and safety laboratory tests. Pharmacokinetic parameters will be evaluated, including plasma concentration and urine analysis of EMP-01 and its major metabolite.

Participants must meet specific inclusion criteria, including being aged between 18 and 55, in good health, and willing to abstain from certain medications and substances during the study period.

The trial is conducted at New Zealand Clinical Research and is sponsored by EmpathBio Australia Pty. Ltd. The principal investigator is Dr Christian Schwabe. The study was registered on ANZCTR with the registration number ACTRN12622001335785 and has been approved by the Central Health and Disability Ethics Committees in New Zealand.

Recruitment for the trial was completed, with the first participant enrolled on May 16, 2023, and the last participant enrolled on July 27, 2023. The study’s primary purpose is treatment-focused, aiming to provide critical data for the ongoing development of EMP-01 in the treatment of PTSD.

Topic Healthy Subjects PTSD
Compound Placebo
Country Australia New Zealand
Visit trial
Status Completed
Results Published No
Start date 16 May 2023
End date 04 August 2023
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 32
Sex All
Age 18- 55
Therapy No

Trial Details

Post-traumatic stress disorder (PTSD) is a serious, chronic, life-threatening psychiatric disorder. To meet the criteria for a diagnosis of PTSD, psychiatric symptoms must be debilitating and occur after experiencing a single traumatic event or repeated traumatic experiences, such as violence, accidents, sexual and/or childhood abuse, natural disasters, terrorism and war. PTSD is a serious and debilitating disorder with a lifetime prevalence of about 1 in 25 people globally. Current treatments rarely result in full disorder remission and generally require long-term and consistent use. Therefore, there is a need to improve and expand therapeutic options for these PTSD patients. This study will provide critical data and will inform the ongoing development of EMP-01 in the treatment of PTSD.

NCT Number ACTRN12622001335785

Sponsors & Collaborators

EmpathBio
EmpathBio is looking to develop MDMA analogues that are both patent-able and should be easier to administer (e.g. shorter duration, with digital/virtual care). EmpathBio is a subsidiary of ATAI.

atai Life Sciences
atai Life Sciences is one of the biggest companies in the psychedelics field. The company aims to be a platform and has nine subsidiary companies working on everything from psilocybin for depression to DMT administration.

Data attribution

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