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

NCT06736912 | Not Yet Recruiting Phase 1

• 1 other identifier: IN_IBA_102
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

• 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

Study Arms (9)

Part I(Cohort I) IN-114199 2.5 mg or Placebo

EXPERIMENTAL

SAD

Drug: IN-114199 2.5mg or placebo

Part I(Cohort 2) IN-114199 5 mg or Placebo

EXPERIMENTAL

SAD and FES

Drug: IN-114199 5mg or placebo

Part I(Cohort 3) IN-114199 10 mg or Placebo

EXPERIMENTAL

SAD and FES

Drug: IN-114199 10mg or placebo

Part I(Cohort 4) IN-114199 20 mg or Placebo

EXPERIMENTAL

SAD and FES

Drug: IN-114199 20mg or placebo

Part I(Cohort 5) IN-114199 40 mg or Placebo

EXPERIMENTAL

SAD

Drug: IN-114199 40mg or placebo

Part II(Cohort I) IN-114199 2.5 mg or Placebo

EXPERIMENTAL

MAD

Drug: IN-114199 2.5mg or placebo

Part II(Cohort 2) IN-114199 5 mg or Placebo

EXPERIMENTAL

MAD

Drug: IN-114199 5mg or placebo

Part II(Cohort 3) IN-114199 10 mg or Placebo

EXPERIMENTAL

MAD

Drug: IN-114199 10mg or placebo

Part II(Cohort 4) IN-114199 20 mg or Placebo

EXPERIMENTAL

MAD

Drug: IN-114199 20mg or placebo

Interventions

IN-114199 2.5mg or placebo DRUG

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

Part I(Cohort I) IN-114199 2.5 mg or Placebo; Part II(Cohort I) IN-114199 2.5 mg or Placebo

IN-114199 10mg or placebo DRUG

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

Part I(Cohort 3) IN-114199 10 mg or Placebo; Part II(Cohort 3) IN-114199 10 mg or Placebo

IN-114199 20mg or placebo DRUG

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

Part I(Cohort 4) IN-114199 20 mg or Placebo; Part II(Cohort 4) IN-114199 20 mg or Placebo

IN-114199 40mg or placebo DRUG

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

Part I(Cohort 5) IN-114199 40 mg or Placebo

IN-114199 5mg or placebo DRUG

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

Part I(Cohort 2) IN-114199 5 mg or Placebo; Part II(Cohort 2) IN-114199 5 mg or Placebo

Eligibility Criteria

• Age: 19 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).

You may not qualify if:

• 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.))

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital, Clinical Trial Center

Seoul, South Korea

Location

Central Study Contacts

Seung Hee Jung, Ph.D

CONTACT

+82-2-6477-0164; shee.jung@inno-n.com

Eun Ji Kim

CONTACT

+82-2-6477-0290; eunji.kim24@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 17, 2024
• Study Start: December 16, 2024
• Primary Completion: August 30, 2025
• Study Completion: November 11, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-11

Locations

KR (1)