A Randomized, Double-blind, Placebo-controlled, Single/multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety/tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
详细描述
Part A: SAD and FES study
- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults
- To compare and evaluate the effects of food on the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults
Part B: MAD study
- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of repeated oral doses of IN-114199 in healthy adults
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged ≥ 19 years and ≤ 63 years on the date of the written informed consent
- •Healthy subjects were defined as individuals who defecated almost every day for ≥ 6 months
- •Body weight of ≥ 40.0 kg and ≤ 100.0 kg, with body mass index (BMI) of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
- •Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.
- •Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, physical examinations, etc.).
排除标准
- •Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
- •Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
- •Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- •Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- •Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.
- •Blood AST(SGOT), and ALT(SGPT) > 60 IU/L at the screening test
- •Showing the following findings on ECG at the screening test: QT > 480 msec(all), QTcB>450(male), QTcB>470(female)
- •Subjects who have taken any drugs known to significantly induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 1 month prior to the expected initial application date.
- •Subjects who have participated in other clinical trials within 6 months prior to the expected initial application date
- •Subjects who have history of regular alcohol consumption exceeding 21 units/week (1 unit = 10 g = 12.5 mL of pure alcohol) or subjects who cannot avoid drinking alcohol from 3 days prior to the expected initial application date to the discharge
- •Subjects who have history of average use of 10 cigarettes daily
- •Subjects who consumed caffeine-containing food (coffee, green tea, black tea, carbonated beverage, coffee-flavored milk, tonics, etc.) or subjects who cannot avoid drinking caffeine-containing food from 3 days prior to the expected initial application date to the discharge
- •Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))
- •Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
研究组 & 干预措施
Part I(Cohort I) IN-114199 2.5 mg or Placebo
SAD
干预措施: IN-114199 2.5mg or placebo (Drug)
Part I(Cohort 2) IN-114199 5 mg or Placebo
SAD and FES
干预措施: IN-114199 5mg or placebo (Drug)
Part I(Cohort 3) IN-114199 10 mg or Placebo
SAD and FES
干预措施: IN-114199 10mg or placebo (Drug)
Part I(Cohort 4) IN-114199 20 mg or Placebo
SAD and FES
干预措施: IN-114199 20mg or placebo (Drug)
Part I(Cohort 5) IN-114199 40 mg or Placebo
SAD
干预措施: IN-114199 40mg or placebo (Drug)
Part II(Cohort I) IN-114199 2.5 mg or Placebo
MAD
干预措施: IN-114199 2.5mg or placebo (Drug)
Part II(Cohort 2) IN-114199 5 mg or Placebo
MAD
干预措施: IN-114199 5mg or placebo (Drug)
Part II(Cohort 3) IN-114199 10 mg or Placebo
MAD
干预措施: IN-114199 10mg or placebo (Drug)
Part II(Cohort 4) IN-114199 20 mg or Placebo
MAD
干预措施: IN-114199 20mg or placebo (Drug)
结局指标
主要结局
Adverse Event
时间窗: Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15)
For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship
Vital Sign
时间窗: Part I : Up to Day 3/ Part II: Up to Day 9
Vital sign results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Physical Examination
时间窗: Part I : Up to Day 3/ Part II: Up to Day 9
Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of IN-114199.
Body Weight in kilograms Measurement
时间窗: Part I : Up to Day 3 / Part II: Up to Day 9
The body weight in kilograms of Subjects will be monitored daily from the administration of IN-114199 until their discharge
12-lead electrocardiogram (ECG)
时间窗: Part I SAD: Up to Day 3 / Part II: Up to Day 9
QT/QTc interval will be recorded and analyzed automatically.
Clinical Laboratory Test
时间窗: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9
Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
次要结局
- PK parameters (Urine and Plasma)(Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9)
- PD parameters (plasma C4 level)(Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9)
- PD parameters (plasma LDL/HDL level)(Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8)