This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants

Официальное название

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

Обзор

This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants

Подробное описание

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

Вмешательства

• Препарат IN-114199 2.5mg or placebo
  IN-114199 2.5mg or placebo (1 Tablet, QD)
• Препарат IN-114199 10mg or placebo
  IN-114199 10mg or placebo (1 Tablet, QD)
• Препарат IN-114199 20mg or placebo
  IN-114199 10mg or placebo (2 Tablets, QD)
• Препарат IN-114199 40mg or placebo
  IN-114199 10mg or placebo (4 Tablets, QD)
• Препарат IN-114199 5mg or placebo
  IN-114199 2.5mg or placebo (2 Tablets, QD)

Первичные конечные точки

• Adverse Event [Срок оценки: 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)]
• Vital Sign [Срок оценки: Part I : Up to Day 3/ Part II: Up to Day 9]
• Physical Examination [Срок оценки: Part I : Up to Day 3/ Part II: Up to Day 9]
• Body Weight in kilograms Measurement [Срок оценки: Part I : Up to Day 3 / Part II: Up to Day 9]
• 12-lead electrocardiogram (ECG) [Срок оценки: Part I SAD: Up to Day 3 / Part II: Up to Day 9]
• Clinical Laboratory Test [Срок оценки: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9]

Вторичные конечные точки (4)

• PK parameters (Urine and Plasma) [Срок оценки: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9]
• PK parameters (Urine and Plasma) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8]

Критерии участия

Критерии включения

• 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.).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital, Clinical Trial Center — Seoul

Идентификаторы

NCT: NCT06736912 · IN_IBA_102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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