A Phase I, Single-center, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Tolerability, Pharmacokinetic, and Food Effect Study of SC1011 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events and serious adverse events related drug.
研究概览
简要总结
The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011,in health conditions. The main questions it aims to answer are:
Safety and tolerability profiles in healthy subjects.Pharmacokinetic profiles in healthy subjects.Food effect in healthy subjects.Participants will complete the study including screening period, dosing period, and observation period. Researchers will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.
详细描述
This is a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Part B will comprise a multiple-dose, sequential-group study.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, of any race, between 18 and 45 years of age, inclusive, at Screening.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator.
- •Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
- •Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- •Alcohol consumption of > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
- •Any screening laboratory or ECG results are not within the normal reference range and are considered clinically significant.
- •Participants who participated in other clinical trials within 3 months prior to administration.
- •Blood donation or blood loss exceeding 400 mL within 2 months prior to administration.
- •Participants who smoked, drank alcohol, tea, food or drink containing xanthine or caffeine, or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion 2 days before drug administration.
- •Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
研究组 & 干预措施
A single dose SC1011 50mg（A1）
Drug: SC1011 tablet Treatment: No food prior to dosing
干预措施: SC1011 (Drug)
A single dose SC1011 150mg（A2）
Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing
干预措施: SC1011 (Drug)
A single dose SC1011 150 mg（A3）
Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing
干预措施: SC1011 (Drug)
A single dose SC1011 300mg（A4）
Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing
干预措施: SC1011 (Drug)
结局指标
主要结局
Incidence and severity of adverse events and serious adverse events related drug.
时间窗: Evaluations will be conducted for up to 7 days after first administration
Adverse events are coded according to the ICH Medical Dictionary of Regulatory Activities (MedDRA 24.0 or above). ADR: Adverse events that are "definitely related, probably related, or undetermined" in relation to the investigational drug.
次要结局
- Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011(Evaluations will be conducted for up to 7 days after first administration)
- Geometric Mean of Maximum Observed Plasma Concentration of SC1011(Evaluations will be conducted for up to 7 days after first administration)