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Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects

Primary Purpose

Healthy Participants

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ID119031166M
Placebo
Sponsored by
IlDong Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Participants focused on measuring First-in-human (FIH), Single ascending doses (SAD), Multiple ascending doses (MAD), Farnesoid X receptor (FXR) agonist, Noncirrhotic non-alcoholic steatohepatitis (NASH), Liver fibrosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Must be Caucasian (White American of European or Latin American descent). Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort. Body mass index (BMI) within the range of 18.5 to 30 kg/m^2 (inclusive) at the time of Screening. No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations. Participants with normal renal function. Women are eligible to participate if not pregnant, not breastfeeding. Male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods. Exclusion Criteria: Currently have an acute disease with active symptoms. History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.). History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias. History of clinically significant hypersensitivity reaction to any drugs or additives. History of any gastrointestinal disease. History of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake. Evidence of moderate or excessive alcohol consumption. Tested positive in viral serology tests (hepatitis B virus [HBV], hepatitis C virus [HCV], and human immunodeficiency virus [HIV]). Known family history or known presence of long QT syndrome. A history of hypokalemia. Use of concomitant medicines that prolong QT/QTc (QT Interval Corrected for Heart Rate). History of active viral hepatitis (hepatitis A, B, C, and E), or autoimmune hepatitis. History of Multiple Endocrine Neoplasia type 2. Solid organ transplantation, except corneal transplants. History or presence of neutropenia which is defined as absolute neutrophil count (ANC) < 1.5 at Screening and admission. Participants with a microalbuminuria.

Sites / Locations

  • California Clinical trials medical group/PAREXELRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

SAD: ID119031166M

MAD: ID119031166M

SAD: Placebo

MAD: Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.

Secondary Outcome Measures

Maximum plasma concentration determined directly from the concentration- time profile (Cmax)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Dose-normalized Cmax
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Dose-normalized AUC0-last
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.

Full Information

First Posted
October 28, 2022
Last Updated
September 7, 2023
Sponsor
IlDong Pharmaceutical Co Ltd
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT05604287
Brief Title
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
Official Title
A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd
Collaborators
Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
Detailed Description
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
First-in-human (FIH), Single ascending doses (SAD), Multiple ascending doses (MAD), Farnesoid X receptor (FXR) agonist, Noncirrhotic non-alcoholic steatohepatitis (NASH), Liver fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAD: ID119031166M
Arm Type
Experimental
Arm Title
MAD: ID119031166M
Arm Type
Experimental
Arm Title
SAD: Placebo
Arm Type
Placebo Comparator
Arm Title
MAD: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ID119031166M
Intervention Description
The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The participant will receive a oral dose of Placebo.
Primary Outcome Measure Information:
Title
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
Description
To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.
Time Frame
From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)
Secondary Outcome Measure Information:
Title
Maximum plasma concentration determined directly from the concentration- time profile (Cmax)
Description
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Time Frame
Day 1-4 for SAD and Day 1-17 for MAD
Title
Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)
Description
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Time Frame
Day 1-4 for SAD and Day 1-17 for MAD
Title
Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)
Description
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Time Frame
Day 1-4 for SAD and Day 1-17 for MAD
Title
Dose-normalized Cmax
Description
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Time Frame
Day 1-4 for SAD and Day 1-17 for MAD
Title
Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)
Description
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Time Frame
Day 1-4 for SAD and Day 1-17 for MAD
Title
Dose-normalized AUC0-last
Description
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Time Frame
Day 1-4 for SAD and Day 1-17 for MAD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be Caucasian (White American of European or Latin American descent). Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort. Body mass index (BMI) within the range of 18.5 to 30 kg/m^2 (inclusive) at the time of Screening. No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations. Participants with normal renal function. Women are eligible to participate if not pregnant, not breastfeeding. Male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods. Exclusion Criteria: Currently have an acute disease with active symptoms. History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.). History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias. History of clinically significant hypersensitivity reaction to any drugs or additives. History of any gastrointestinal disease. History of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake. Evidence of moderate or excessive alcohol consumption. Tested positive in viral serology tests (hepatitis B virus [HBV], hepatitis C virus [HCV], and human immunodeficiency virus [HIV]). Known family history or known presence of long QT syndrome. A history of hypokalemia. Use of concomitant medicines that prolong QT/QTc (QT Interval Corrected for Heart Rate). History of active viral hepatitis (hepatitis A, B, C, and E), or autoimmune hepatitis. History of Multiple Endocrine Neoplasia type 2. Solid organ transplantation, except corneal transplants. History or presence of neutropenia which is defined as absolute neutrophil count (ANC) < 1.5 at Screening and admission. Participants with a microalbuminuria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Operation Team
Phone
82-2-526-3192
Email
hhkim@ildong.com
Facility Information:
Facility Name
California Clinical trials medical group/PAREXEL
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Yoon, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects

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