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 VolunteersSafety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

Field Trip Psychedelics Inc0 个研究点目标入组 48 人开始时间: 2022年5月18日最近更新: 2023年4月24日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 48

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 65 Years（—）
性别: All

入选标准

•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.

排除标准

•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 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),

研究者

发起方

Field Trip Psychedelics Inc

相似试验

已完成

不适用

A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of BMS-207940, a Selective Endothelina Receptor, Antangonist, in Subjects with Intermittent Claudicatio-I739 Peripheral vascular disease, unspecifiedPeripheral vascular disease, unspecifiedI739

PER-033-00BRISTOL MYERS SQUIBB PERU S.A.,

进行中（未招募）

1 期

This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEBiliary AtresiaMedDRA version: 20.0Level: LLTClassification code 10004653Term: Biliary atresiaSystem Organ Class: 100000004850

EUCTR2019-003807-37-PLAlbireo AB245

已完成

不适用

A Study Evaluating the Nutritional Supplement on Skin Parameters in Healthy Female SubjectsHealthy adult

JPRN-UMIN000039177TTC Co., Ltd66

进行中（未招募）

1 期

EUCTR2019-003807-37-HUAlbireo AB200

已完成

不适用

Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertensio-I10 Essential (primary) hypertensionEssential (primary) hypertensionI10

PER-025-08TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,