A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose Phase I Study to Assess the Safety, Pharmacokinetics and Effect of Food on Orally Administered DS102 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- DS Biopharma
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose
研究概览
简要总结
The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.
DS102 capsules will be orally administered for up to 4 weeks, and will be compared against placebo.
The study will enrol approximately 56 adult subjects.
详细描述
There will be 7 cohorts enrolled, each consisting of 8 subjects.
Cohorts 1 - 4 will be orally administered up to 2000mg single doses of DS102 on Day 1.
Cohorts 5 - 7 will be orally administered up to 2000mg multiple daily doses of DS102 for 28 days.
The primary objective is to assess the safety and plasma pharmacokinetics of single and multiple daily oral doses of DS102.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, 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
- •Subject is male or female and is aged between 18 and 45 years inclusive.
- •Subject's body mass index (BMI) is between 18.0 and 30.0 kg/m2 inclusive.
- •Subject is a non-smoker, has been a non-smoker for 3 months prior to screening and has a negative urine cotinine test at screening.
排除标准
- •Subject has had a clinically significant illness in the 4 weeks before screening.
- •Use of prescribed medication in the 2 weeks before dosing or over-the-counter preparations (including vitamins and supplements) for 1 week before dosing
- •Subject has a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening or Day -
- •Subject with a history of alcohol abuse in the opinion of the Investigator, or who currently drinks in excess of 28 units per week (males) or 21 units per week (females), whereby a unit consists of 10ml or 8mg of pure alcohol, or who have a positive alcohol urine test at screening or Day -
- •Subject has participated in any other clinical study with an investigational drug/device within 3 months before the first day of administration of study treatment.
- •Subject has a positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
- •Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
- •Subject has donated blood or blood products within 3 months before screening.
- •Subject has known hypersensitivity to any ingredients of the study treatment.
研究组 & 干预措施
DS102 500mg Multiple Dose
Taken orally once a day for 28 days by Cohort 5
干预措施: DS102 (Drug)
Placebo
Taken orally as a single dose (Cohorts 1 - 4) Taken orally as a multiple daily dose for 28 days (Cohorts 5 - 7)
干预措施: Placebo (Drug)
DS102 100mg Single Dose
Taken orally once by Cohort 1
干预措施: DS102 (Drug)
DS102 500mg Single Dose
Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect)
干预措施: DS102 (Drug)
DS102 1000mg Single Dose
Taken orally once by Cohort 3
干预措施: DS102 (Drug)
DS102 2000mg Single Dose
Taken orally once by Cohort 4
干预措施: DS102 (Drug)
DS102 1000mg Multiple Dose
Taken orally once a day for 28 days by Cohort 6
干预措施: DS102 (Drug)
DS102 2000mg Multiple Dose
Taken orally once a day for 28 days by Cohort 7
干预措施: DS102 (Drug)
结局指标
主要结局
Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall safety of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by Vz/F ) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by Vz/F) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a single dose
时间窗: 14 days
Phase I study - Overall PK of product in first in man study
Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a multiple dose for 28 days
时间窗: 42 days
Phase I study - Overall safety of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by AUC 0-24) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
Pharmacokinetics (Plasma concentrations assessed by Css) of DS102 administered as a multiple dose
时间窗: 42 days
Phase I study - Overall PK of product in first in man study
次要结局
未报告次要终点