A Double-Blind, Randomized, Placebo-Controlled... — Clinical Trial Details

Phase I, cohort-based, single-ascending dose study of subcutaneous FT-104 HCl in healthy volunteers with up to six cohorts (each up to 8 participants; sentinel dosing and Safety Review Committee–managed escalation).

Primary endpoints are safety, tolerability and PK (Cmax, Tmax, AUCs, t1/2) with intensive sampling through 24 hours and a follow-up visit at Day 10. Safety monitoring includes AEs/SAEs, vitals, ECG, labs and injection-site assessments; suicidality monitored using C-SSRS.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

18 - 30

Psychosis History

Excluded

Inclusion Criteria

1. Signed informed consent in a language understandable to the subject prior to any study-related procedure.
2. The subject has at least one prior recreational experience with hallucinogenic or psychedelic compounds.
3. The subject weighs at least 60kg and has a BMI between 18 - 30 kg/m2.
4. Women of childbearing potential (WOCBP) must be non-lactating and have a negative pregnancy test. Females who are not WOCBP must be either surgically sterile or post-menopausal.
5. In the opinion of the investigator, the subject is capable of understanding and is willing and able to comply with all conditions and requirements of the study.

Exclusion Criteria

1. Subject has current or a history of any clinically significant illness which may affect safety, or potentially confound the study results.
2. 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.
3. 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.
4. Immediate (1st degree) blood-related family members, or personal currently or previously diagnosed with psychotic or bipolar disorder.
5. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to screening.
6. Subject has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to screening.
7. Previous major adverse response to a hallucinogenic or psychedelic drug, as determined by the qualified/trained investigator.
8. 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.
9. Use of synthetic or naturally-occurring cannabinoids from 28 days prior to study drug administration and agree not to use through to EOS/ET.
10. Subject has a positive cotinine at screening or on Day -1.
11. Positive alcohol breath test or urine screen for drugs of abuse at screening or on Day -1.
12. Subject has a history of drug abuse.
13. Excessive alcohol consumption.
14. Consumption of products containing caffeine, xanthine or poppy seeds from 48 hours prior to study drug administration until last PK sample had been collected.
15. Participation in another clinical study involving study treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.
16. Administration of any vaccine within 28 days prior to study drug administration and through to EOS/ET.
17. 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.
18. Any positive results for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody and human immunodeficiency virus (HIV) at screening.
19. 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.
20. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG).

Company

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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)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

Integration

Study Arms & Interventions

FT-104 HCl (subcutaneous)

Interventions

Placebo (saline)

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details