NCT04971135Unknown1 期
A Phase 1 Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of SAN711 in Healthy Participants
Saniona1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Treatment-emergent Adverse Events (TEAEs) [SAD]
研究概览
简要总结
Phase 1, first-in-human, double-blind, randomized, placebo-controlled, parallel group, single ascending dose (SAD) and multiple ascending dose (MAD) study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, determined by Screening medical evaluation (medical history, physical examination, vital signs, safety 12-lead electrocardiogram [ECG], and clinical laboratory evaluations, including liver and renal function tests which must be within normal limits)
- •Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive at Screening
- •Non-smoker (and no other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (<500 ng/mL) at the Screening Visit and admission
- •Female participants must be women of non-childbearing potential (WONCBP); defined as follows: surgically sterile (ie, had a hysterectomy, or bilateral oophorectomy, or bilateral salpingectomy ≥6 months prior to the first dose of study drug); or Postmenopausal (no menses) for at least 1 year prior to the first dose of study drug. Postmenopausal status must be confirmed by FSH testing at screening
排除标准
- •Participant has a history or evidence of any clinically significant cardiovascular, general gastrointestinal, endocrine, hematologic, hepatic, immunological, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the investigator
- •Participant answers "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the Columbia Suicide Severity Rating Scale
- •Participant's current alcohol intake exceeds 14 units/week for men and women (1 unit = half pint of beer, 1 glass of wine, 1 measure of spirits)
- •Participant is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to check-in Day and until final discharge Day inclusive
- •Participant is unwilling to avoid consumption of caffeine-containing beverages within 48 hours prior to day of admission until final discharge day
- •Participant has a history of illicit substance use OR a positive urine drug test (eg, cocaine, amphetamines, methylenedioxymethamphetamine (MDMA), barbiturates, opiates, benzodiazepines, or cannabinoids) or urine alcohol test at the Screening Visit or admission
- •Participant has a positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C, or HBsAg negative/anti-HBc positive/anti-HBs negative, or human immunodeficiency virus (HIV) 1 and/or -2 antibodies
- •At Screening and Baseline, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, or diastolic blood pressure (DBP) greater than 90 or less than 40 mm Hg, in the supine position, at screening or baseline. Borderline values (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) will be repeated. Subjects can be included if the repeat value is within range or still borderline, but deemed not clinically significant by the investigator
- •Corrected QT interval using Fridericia's formula >450 msec for males and >470 msec for females
- •Resting bradycardia (heart rate [HR] <40 beats per minute [bpm]) or tachycardia (HR >100 bpm)
- •Personal or family history of congenital long QT syndrome or sudden death
- •Screening or Admission ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate QT measurement (eg, neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves)
- •Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker at screening or on admission
- •Receipt of COVID-19 vaccine within 2 weeks prior to baseline or scheduled for vaccination during the study
- •COVID-19 infection within 90 days of screening or evidence of current COVID-19 infection within the past 4 weeks at screening, between screening and admission, or at admission
- •If unvaccinated for COVID-19, contact with an individual with COVID-19 infection in the past 14 days at screening, between screening and admission, or at admission
研究组 & 干预措施
SAN711 (SAD)
Experimental
6 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of SAN711
干预措施: SAN711 (Drug)
Placebo (SAD)
Placebo Comparator
2 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of Placebo
干预措施: Placebo (Other)
SAN711 (MAD)
Experimental
6 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of SAN711
干预措施: SAN711 (Drug)
Placebo (MAD)
Placebo Comparator
2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Treatment-emergent Adverse Events (TEAEs) [SAD]
时间窗: Initiation of dosing through 96 hours post dosing
Incidence of TEAEs during SAD
TEAEs [MAD]
时间窗: Initiation of dosing through 16 days post dosing
Incidence of TEAEs during MAD
Adverse Events of Special Interest (AESIs) [SAD]
时间窗: Initiation of dosing through 96 hours post dosing
Incidence of AESIs during SAD
AESIs [MAD]
时间窗: Initiation of dosing through 16 days post dosing
Incidence of AESIs during MAD
次要结局
- PK Parameters: Tmax [SAD](Baseline (Predose) through 96 hours post dosing)
- PK Parameters: Tmax [MAD](Day 1 (Predose) through Day 16)
- PK Parameters: t1/2 [SAD](Baseline (Predose) through 96 hours post dosing)
- PK Parameters: t1/2 [MAD](Day 1 (Predose) through Day 16)
- PK Parameters: AUC-last [SAD](Baseline (Predose) through 96 hours post dosing)
- PK Parameters: AUC-last [MAD](Day 1 (Predose) through Day 16)
- PK Parameters: AUC-inf [SAD](Baseline (Predose) through 96 hours post dosing)
- PK Parameters: Cmax [SAD](Baseline (Predose) through 96 hours post dosing)
- PK Parameters: Cmax [MAD](Day 1 (Predose) through Day 16)
- PK Parameters: AUC-inf [MAD](Day 1 (Predose) through Day 16)
研究者
研究点 (1)
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