NCT05484414已完成1 期
A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Oral Doses of SRP-3D (DA), and to Characterize the Effect of Food on the Pharmacokinetics of SRP-3D (DA), in Healthy Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This is a two-part randomized, double-blind, placebo-controlled study.
详细描述
This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female. Females must not be pregnant or breastfeeding.
- •Is between 18 and 55 years of age (inclusive).
- •Able to speak and understand English or Spanish.
- •Agrees to comply with testing procedures.
- •Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
- •The subject meets good health criteria.
- •Females of non-childbearing potential or agree to use birth control.
- •Male subjects must be surgically sterile or agree to the use birth control.
- •Agree to the confinement period and return for the outpatient visits.
- •Has vital signs at screening within appropriate ranges.
排除标准
- •History or presence of clinically significant diseases.
- •Abnormal diet 4 weeks preceding the first dose of study medication.
- •Received any investigational product in a clinical study.
- •Previously been administered IMP in this study.
- •Taking any prescribed or OTC drug.
- •Taking moderate or strong inhibitors/inducers of cytochrome P
- •History of hypersensitivity to acetaminophen or similar chemical entities.
- •Presence or history of allergy or blood or plasma donation.
- •Blood or plasma donation.
- •Smokers and those who have smoked within the last 12 months.
- •Current users of e-cigarettes and nicotine replacement products.
- •Consumption of prohibited beverages or foods.
- •Prior history of substance abuse or treatment.
- •Regular alcohol consumption.
- •Positive alcohol urine test at screening or admission.
- •Is a female with a positive pregnancy test result.
- •Positive urine screen for drugs of abuse.
- •Positive test for hepatitis B or C, or HIV.
- •Active infection, periodontal disease, certain dental appliances.
- •Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- •Significant serious skin disease.
- •Cohort 3 only: history of cholecystectomy or gall stones.
- •Have poor venous access that limits phlebotomy.
- •Evidence of current SARS-CoV-2 infection.
- •Clinically significant abnormal clinical chemistry, hematology or urinalysis.
- •Immediate family members of a study site or Sponsor employee.
- •Failure to satisfy the Investigator of fitness to participate.
研究组 & 干预措施
Placebo
Placebo Comparator
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
干预措施: Placebo (Drug)
Experimental
Experimental
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
干预措施: SRP-3D (diethylamide) (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: The time of providing written informed consent until 30 days after the last dose of study drug
Reported AEs
次要结局
- PK parameters 1(6 days)
- PK parameters 2(6 days)
- PK parameters 3(6 days)
- PK parameters 4(6 days)
- PK parameters 5(6 days)
- PK parameters 6(6 days)
- PK parameters 7(6 days)
- PK parameters 8(6 days)
- PK parameters 9(6 days)
- PK parameters 10(6 days)
研究者
研究点 (2)
Loading locations...
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