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

December 15, 2024 updated by: HK inno.N Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital, Clinical Trial Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part I(Cohort I) IN-114199 2.5 mg or Placebo
SAD
Drug: IN-114199 2.5mg or placebo
IN-114199 2.5mg or placebo (1 Tablet, QD)
Experimental: Part I(Cohort 2) IN-114199 5 mg or Placebo
SAD and FES
Drug: IN-114199 5mg or placebo
IN-114199 2.5mg or placebo (2 Tablets, QD)
Experimental: Part I(Cohort 3) IN-114199 10 mg or Placebo
SAD and FES
Drug: IN-114199 10mg or placebo
IN-114199 10mg or placebo (1 Tablet, QD)
Experimental: Part I(Cohort 4) IN-114199 20 mg or Placebo
SAD and FES
Drug: IN-114199 20mg or placebo
IN-114199 10mg or placebo (2 Tablets, QD)
Experimental: Part I(Cohort 5) IN-114199 40 mg or Placebo
SAD
Drug: IN-114199 40mg or placebo
IN-114199 10mg or placebo (4 Tablets, QD)
Experimental: Part II(Cohort I) IN-114199 2.5 mg or Placebo
MAD
Drug: IN-114199 2.5mg or placebo
IN-114199 2.5mg or placebo (1 Tablet, QD)
Experimental: Part II(Cohort 2) IN-114199 5 mg or Placebo
MAD
Drug: IN-114199 5mg or placebo
IN-114199 2.5mg or placebo (2 Tablets, QD)
Experimental: Part II(Cohort 3) IN-114199 10 mg or Placebo
MAD
Drug: IN-114199 10mg or placebo
IN-114199 10mg or placebo (1 Tablet, QD)
Experimental: Part II(Cohort 4) IN-114199 20 mg or Placebo
MAD
Drug: IN-114199 20mg or placebo
IN-114199 10mg or placebo (2 Tablets, QD)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
Part I : Up to Day 3/ Part II: Up to Day 9
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.
Part I : Up to Day 3/ Part II: Up to Day 9
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
Part I : Up to Day 3 / Part II: Up to Day 9
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.
Part I SAD: Up to Day 3 / Part II: Up to Day 9
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
Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
AUClast
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)
Time Frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
AUEClast
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)
Time Frame: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8
AUEClast
Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HK inno.N Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IN_IBA_102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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