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

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

This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: ID119031166M; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Ops Study Leader; Phone Number: 82-2-526-3386; Email: wonkyung.lee@yunovia.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Recruiting
      • California Clinical trials medical group/PAREXEL
      • Contact: Esther Yoon, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.
• Hemoglobin levels below 12.0 g/dL at Screening or Baseline.
• White Blood Cell levels below 3.5 × 109/L at Screening or Baseline.
• Platelet count < 150,000/µL, international normalized ratio (INR) > 1.5, albumin < 3.5 g/dL

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD: ID119031166M	Drug: ID119031166M; The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
Experimental: MAD: ID119031166M	Drug: ID119031166M; The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
Placebo Comparator: SAD: Placebo	Drug: Placebo; The participant will receive a oral dose of Placebo.
Placebo Comparator: MAD: Placebo	Drug: Placebo; The participant will receive a oral dose of Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1-4 for SAD and Day 1-17 for MAD
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.	Day 1-4 for SAD and Day 1-17 for MAD
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.	Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized Cmax	To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.	Day 1-4 for SAD and Day 1-17 for MAD
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.	Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized AUC0-last	To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.	Day 1-4 for SAD and Day 1-17 for MAD

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd
• Collaborators: Parexel; YUNOVIA CO.,LTD.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Liver fibrosis; First-in-human (FIH); Single ascending doses (SAD); Multiple ascending doses (MAD); Farnesoid X receptor (FXR) agonist; Noncirrhotic non-alcoholic steatohepatitis (NASH)
• Other Study ID Numbers: ID119031166M-NASH-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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