A study to assess two formulations of VLS-01 (VLS-01-IV and VLS-01-BU) in Healthy Adult Volunteers
- Conditions
- DepressionMental Health - Depression
- Registration Number
- ACTRN12624000025538
- Lead Sponsor
- atai Therapeutics Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 16
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method