A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of SBS-1000 Administered by Intravenous Infusion to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events (AEs)
研究概览
简要总结
This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.
详细描述
This study will be a single-center (clinical research unit), double-blind, placebo-controlled, randomized, adaptive, single-ascending dose study receiving either Investigational Product (IP [SBS-1000]) or placebo IV infusion. Up to 56 subjects will be randomized.
A total of 6 ascending dose cohorts will be used to assess the MTD of SBS-1000. Each cohort will be comprised of up to 8 subjects randomized 6:2 (IP:placebo). A sentinel group of 2 subjects randomized 1:1 (IP:placebo) will be used for each cohort with the sentinel group being dosed at least 48 hours prior to dosing the remaining subjects of the cohort, and contingent on the results of ongoing safety evaluation.
Blood samples will be collected over 72 hours postdose and urine samples over 48 hours postdose for pharmacokinetic (PK) assessments in all cohorts. Pharmacodynamic assessments will be performed throughout the study in cohorts 1 through 6. The sampling parameters may be adjusted based on the interim safety review.
Once the maximum tolerated dose (MTD) is established, dosing with the MTD or a lower dose, as determined by an interim safety review, an additional cohort (7) will occur to investigate the cardiodynamic effects of SBS-1000 using Holter monitoring. Cohort 7 will be comprised of 8 subjects randomized 6:2 (IP:placebo). No sentinel dosing administration will occur in this cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form (ICF)
- •Healthy adult male or female, aged 18 to 59 years, inclusive, at Screening
- •Body mass index (BMI) within 18.0 kg/m^2 to 33.0 kg/m^2, inclusively
- •Minimum body weight of at least 50.0 kg at Screening
- •Willingness to comply with all study procedures
- •If female, agrees to use an acceptable contraceptive method.
- •If male, agrees to use an acceptable contraceptive method.
- •Healthy as determined by no clinically significant findings at screening and clinic admission.
- •Non- or ex-smoker
排除标准
- •Has a current medical condition that would affect sensitivity to cold or pain
- •Personal or family history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic, or other clinically significant disease that may interfere with the study
- •Any clinically significant illness in the 28 days prior to the first study drug administration
- •Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy
- •Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Any clinically significant laboratory results at screening or prior to the first drug administration
- •intake of an investigational product within 28 days prior to study drug administration.
- •Positive test for alcohol and/or drugs of abuse
- •Positive for HIV or hepatitis
- •Donation of plasma 7 days prior to study drug administration and/or donation of blood within 56 days prior to study drug administration.
- •Significant ECG abnormalities
研究组 & 干预措施
SBS-1000
Investigational Product
干预措施: SBS-1000 (Drug)
Placebo
Normal saline (0.9% sodium chloride [NaCl])
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs)
时间窗: From start of infusion to 4 (±2) days after the last blood draw in the study
Adverse events as assessed by electrocardiogram, vital signs, end-tidal carbon dioxide, oxygen saturation, physical examination, clinical laboratory tests, OAAS, C-SSRS, slit-lamp examination, gastrointestinal/esophageal assessment and concomitant medications
次要结局
- Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000(From start of infusion to 72 hours post-infusion)