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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604287
• Other study ID #: ID119031166M-NASH-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 10, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: IlDong Pharmaceutical Co Ltd
• Contact: Clinical Ops Study Leader
• Phone: 82-2-526-3386
• Email: wonkyung.lee[@]yunovia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• ID119031166M
The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
• Placebo
The participant will receive a oral dose of Placebo.

Locations

Country	Name	City	State
United States	California Clinical trials medical group/PAREXEL	Glendale	California

Sponsors (3)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd	Parexel, YUNOVIA CO.,LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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