Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects

A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics After a Single Oral Administration of ID110521156 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult sbujects. This is the first clinical study of ID110521156.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: ID110521156; Drug: Placebo of ID110521156

• Study Type: Interventional
• Enrollment (Estimated): 32
• 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

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Seunghwan Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy subjects aged 19 to 55 years at the time of Screening.
• Body mass index (BMI) within 18.5 to 29.9 kg/m2; and a total body weight ≥ 40 kg, ≤ 90 kg
• Evidence of a personally signed and dated informed consent document indicating that the subject hasbeen informed of all pertinent aspects of the study
• For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal(including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (includingdrug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
• Treatment with an investigational drug (including a bioequivalence study) within 6 months prior to the scheduled date of administration of the investigational product.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception forthe duration of the study and for at least 3 months after the last dose.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.	Drug: ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Drug: Placebo of ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Other Names: Placebo
Experimental: Cohort 2; The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.	Drug: ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Drug: Placebo of ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Other Names: Placebo
Experimental: Cohort 3; The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.	Drug: ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Drug: Placebo of ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Other Names: Placebo
Experimental: Cohort 4; The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.	Drug: ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Drug: Placebo of ID110521156; subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs/serious AEs (SAEs)	Incidence and severity of ad adverse event	Throughout study duration, up to 9 days
Percentage of subjects with clinically significant change from baselin in vital signs, ECG, safety laboratory test restuls		Throughout study duration, up to 9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Cmax)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Area under the plasma drug concentration-time curve from 0 to last, (AUClast)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
The time of peak concentration,(Tmax)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Terminal half-life (T1/2)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Apparent clearance (CL/F)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Apparent volume of distribution after extravascular administration (Vd/F)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Amount excreted in urine (Ae)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Renal Clearance (CLr)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Fraction excreted unchanged of an administered dose (fe)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): June 28, 2024
• Study Completion (Estimated): June 28, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ID110521156-T2DM-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: No
• Studies a U.S. FDA-regulated device product: No