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

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: Not yet recruiting
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: IN-114199 2.5mg or placebo; Drug: IN-114199 5mg or placebo; Drug: IN-114199 10mg or placebo; Drug: IN-114199 20mg or placebo; Drug: IN-114199 40mg or placebo

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: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Seung Hee Jung, Ph.D; Phone Number: +82-2-6477-0164; Email: shee.jung@inno-n.com
• Study Contact Backup: Name: Eun Ji Kim; Phone Number: +82-2-6477-0290; Email: eunji.kim24@inno-n.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital, Clinical Trial Center
    • Contact: Seung Hwan Lee, MD, PhD; Phone Number: +82-2-2072-2343; Email: leejh413@snu.ac.kr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Adverse Event	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	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	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	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)	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	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

Outcome Measure	Measure Description	Time Frame
PK parameters (Urine and Plasma)	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)	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)	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)	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

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): November 11, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID 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