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NCT Number: NCT06736912

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

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

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Key information

Age range

19 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.).

Exclusion criteria

  • 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.

Treatment and study plan

IN-114199 2.5mg or placebo

Drug

IN-114199 2.5mg or placebo (1 Tablet, QD)

IN-114199 10mg or placebo

Drug

IN-114199 10mg or placebo (1 Tablet, QD)

IN-114199 20mg or placebo

Drug

IN-114199 10mg or placebo (2 Tablets, QD)

IN-114199 40mg or placebo

Drug

IN-114199 10mg or placebo (4 Tablets, QD)

IN-114199 5mg or placebo

Drug

IN-114199 2.5mg or placebo (2 Tablets, QD)

Primary outcomes

  1. Adverse Event

    Time frame: 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

  2. Vital Sign

    Time frame: 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

  3. Physical Examination

    Time frame: 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.

  4. Body Weight in kilograms Measurement

    Time frame: 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

  5. 12-lead electrocardiogram (ECG)

    Time frame: Part I SAD: Up to Day 3 / Part II: Up to Day 9

    QT/QTc interval will be recorded and analyzed automatically.

  6. Clinical Laboratory Test

    Time frame: 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

Secondary outcomes

  1. PK parameters (Urine and Plasma)

    Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9

    Cmax

  2. PK parameters (Urine and Plasma)

    Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9

    AUClast

  3. PD parameters (plasma C4 level)

    Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9

    AUEClast

  4. PD parameters (plasma LDL/HDL level)

    Time frame: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8

    AUEClast

Study contacts

Contact information is provided by the study sponsor or research team.

Eun Ji Kim

CONTACT

[email protected]

+82-2-6477-0290

Seung Hee Jung, Ph.D

CONTACT

[email protected]

+82-2-6477-0164

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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