None listed
Conditions
Brief summary
Depression and anxiety are common mental health disorders that result in individual suffering and have a significant socio-economic impact. In New Zealand, approximately 1 in 7 people will experience depression during their lifetime. Traditional antidepressants often take weeks to months to positively affect mood but are ineffective in approximately 30% of all patients, which often leads to treatment resistant depression (TRD). Treatment of TRD is difficult and may include different pharmacological treatments, or brain stimulation therapies (which are often accompanied by intolerable side effects). However, no single treatment is effective for all TRD patients and there is a significant medical need for effective TRD therapies that are fast-acting and less invasive. As such, there is an urgent need to improve and expand therapeutic options for these TRD patients. This study will provide critical data and will inform the ongoing development of VLS-01 in the treatment of TRD.
Interventions
The participants will receive a total of 4 administrations of VLS-01 administered via IV (VLS-01 IV) in treatment period 1 and via buccal administration (VLS-01-BU) in treatment period 2 .
Dose:
VLS-01-IV: Single dose of 30 mg is a 57 minute IV infusion which will be administered by a registered nurse and monitored on site.
VLS-01-BU: Single doses of either 240mg or 160 mg, and 60 mg, and 20 mg with option to modify dose.. This is administered approximately 28 days after completion of treatm
The participants will receive a total of 4 administrations of VLS-01 administered via IV (VLS-01 IV) in treatment period 1 and via buccal administration (VLS-01-BU) in treatment period 2 . Dose: VLS-01-IV: Single dose of 30 mg is a 57 minute IV infusion which will be administered by a registered nurse and monitored on site. VLS-01-BU: Single doses of either 240mg or 160 mg, and 60 mg, and 20 mg with option to modify dose.. This is administered approximately 28 days after completion of treatment period 1.. Duration of administration; single day – until dissolved and monitored on site. Dosage based on Phase 1a study. The Safety Monitoring Group (SMG) will review safety, tolerability, PK, and PD results, where available, after the last participant completes each of the first two doses of VLS-01-BU. The moderate and low doses may be modified by the SMG based on observed PK and PD to ensure that the three doses of VLS-01-BU produce a sufficient range of PK and PD effects Dosing is performed on site under supervision of site staff.
Sponsors
atai Therapeutics Pty. Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply: 1. Participant must be 18 to 65 years of age (inclusive) at the time of signing the informed consent. 2. Participants who are overtly healthy as determined by medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and laboratory safety tests performed at the Screening Visit and or before the first dose of IMP. 3. Participants who are not lactating or pregnant as confirmed by a serum pregnancy test at Screening and negative urine pregnancy test before dosing (applies only to participants of childbearing potential [POCBP]). 4 Body weight no greater than 100 kg and body mass index (BMI) within the range 20-32 kg per m2 (inclusive) at Screening. 5.Participant agrees to comply with using a double barrier method of contraception or sexual abstinence and not donate sperm or ova. 6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 7. Smoke no more than 8 cigarettes, pipes, cigars, e-cigarettes or equivalent per month, including nicotine products, from 3 months prior to Screening and is willing to abstain from smoking/using nicotine products for 24 hours before VLS-01 administration and during the entire dosing Visit. 8. Agrees to be available for all study Visits and cooperates fully with the requirements of the study protocol, including the Schedule of Assessments.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: 1. Current or past history schizophrenia or other psychotic disorders, or bipolar I or II disorder, has a past or current history of a significant mental, behavioral, or neurodevelopmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition including, but not limited to, diagnoses of: organic, including symptomatic, mental disorders; mental and behavioral disorders due to psychoactive substance use; schizophrenia, schizotypal, and delusional disorders; mood (affective) disorders (only current diagnosis exclusionary); neurotic, stress-related and somatoform disorders; or disorders of adult personality and behavior. 2. Has a mild, moderate, or severe substance use disorder (drug or alcohol) within the 6 months before Screening and/or history of moderate or severe substance use disorder (drug or alcohol) within the previous 5 years before Screening. 3. Has homicidal ideation or intent per the investigator’s clinical judgment. 4. Risk of suicide as determined by Columbia Suicide Severity Scale (C-SSRS). 5. Has a history of clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, including but not limited to unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, bradycardia, or tachycardia. 6. History of seizures, convulsions or increased intra-cranial pressure except for pediatric febrile seizures. 7. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before Screening. 8. History of risk factors including hypokalemia or a family history of Long QT Syndrome. 9. Has clinically relevant long-term coronavirus disease-2019 (COVID-19) symptoms or current signs or symptoms of COVID-19. 10. Has a biological 1st degree relative with schizophrenia, bipolar I/II, and/or psychotic disorder (unless induced by substance or medical condition). 11. Has a history of greater than 25 lifetime administrations of psychedelic drugs, and/or last use of a psychedelic drug within 6 months before Screening and/or has reported HPPD or other significant AEs after prior use of hallucinogens 12. Is unable or unwilling to refrain from using any recreational psychoactive drugs (other than tobacco and nicotine products), including alcohol, from 24 hours before the start of IMP infusion until 24 hours after dosing has been completed on dosing days. 13. Is unable or unwilling to refrain from using tobacco and nicotine products for 24 hours before the start of IMP administration until the end of the dosing Visit on each dosing day. 14. Has donated blood or plasma within 30 days before Screening, lost more than 500 mL of whole blood within the 30 days before Screening, or received a blood transfusion within 1 year before Screening
Outcome results
None listed