A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers Safety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

Exclusion Criteria20

• Subject has current or a history of any clinically significant illness which may affect safety, or potentially confound the study results.
• Subject has current or a history of clinically significant mental disorders as assessed by questionnaire and interview by a qualified medical personnel professional at screening.
• Subject has a risk of suicide per the Columbia-Suicide Severity Rating Scale (C-SSRS) or has a history of suicidal ideation or suicidal behavior.
• Immediate (1st degree) blood-related family members, or personal currently or previously diagnosed with psychotic or bipolar disorder.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to screening.
• Subject has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to screening.
• Previous major adverse response to a hallucinogenic or psychedelic drug, as determined by the qualified/trained investigator.
• Use of ayahuasca, kambó, yopo, ibogaine, psilocybin, dimethyltryptamine (DMT), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), lysergic acid diethylamide (LSD), Syrian Rue, or other psychedelic agents or mixtures in their synthetic or naturally-occurring form, and use of amphetamines, opioids, or 3,4-Methylenedioxymethamphetamine (MDMA), in the 90 days before screening and through to EOS/ET.
• Use of synthetic or naturally-occurring cannabinoids from 28 days prior to study drug administration and agree not to use through to EOS/ET.
• Subject has a positive cotinine at screening or on Day -1.
• Positive alcohol breath test or urine screen for drugs of abuse at screening or on Day -1.
• Subject has a history of drug abuse
• Excessive alcohol consumption
• Consumption of products containing caffeine, xanthine or poppy seeds from 48 hours prior to study drug administration until last PK sample had been collected.
• Participation in another clinical study involving study treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.
• Administration of any vaccine within 28 days prior to study drug administration and through to through to EOS/ET.
• Use of any psychoactive medication (e.g., a selective serotonin reuptake inhibitor such as paroxetine or citalopram) haloperidol or a medication with monoamine oxidase (MAO) activity (such as isocarboxazid, phenelzine, selegiline or tranylcypromine, linezolid, and methylene blue) within 28 days prior to study drug administration and through to EOS/ET.
• Any positive results for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody and human immunodeficiency virus (HIV) at screening.
• Resting (for at least 5 minutes) systolic blood pressure > 140 or < 90 mmHg or resting diastolic blood pressure > 90 or < 40 mmHg; Resting (for at least 5 minutes) pulse rate outside the range of < 40 or > 100 beats/min at screening or at any time point prior to study drug administration.
• Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG),