Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects

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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: ID110521156; Drug: Placebo of 110521156

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Ops Study Leader; Phone Number: +82-10-4570-1405; Email: eh.hong@yunovia.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Seunghwan Lee; Phone Number: +82-2-741-4221

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy subjects aged 19 to 50 years at the time of Screening.
• Body mass index (BMI) within ≥27 kg/m2; and a total body weight ≥ 50 kg
• Evidence of a personally signed and dated informed consent document indicating that the subject has been 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 hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies.
• Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)	Drug: ID110521156; ID110521156 capsules taken orally once daily; Drug: Placebo of 110521156; ID110521156 placebo capsules taken orally once daily
Experimental: Cohort 2; Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)	Drug: ID110521156; ID110521156 capsules taken orally once daily; Drug: Placebo of 110521156; ID110521156 placebo capsules taken orally once daily
Experimental: Cohort 3; Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)	Drug: ID110521156; ID110521156 capsules taken orally once daily; Drug: Placebo of 110521156; ID110521156 placebo capsules taken orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AEs/serious AEs (SAEs)	Throughout study duration, up to 47 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration of drug in plasma (Cmax)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
Area under the plasma drug concentration-time curve during a dosing interval (AUCtau)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
The time of peak concentration (Tmax)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
Terminal half-life (t1/2)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
Apparent clearance (CL/F)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
Apparent volume of distribution after extravascular administration (Vd/F)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
Renal clearance (CLR)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
fe	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Day 1 and Day 28
Trough plasma concentration taken directly before the next dose (Ctrough)	To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.	Throughout study duration, up to 27 days
Minimum concentration of drug in plasma at steady state (Cmin, ss)	To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.	Day 28
Average concentration of drug in plasma at steady state (Cavg, ss)	To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.	Day 28
peak to trough fluctuation (PTF)	To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.	Day 28
accumulation ratio (R)	To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.	Day 28
Serum glucose	To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.	up to 28 days
Insulin	To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.	up to 28 days
Hemoglobin A1c (HbA1c)	To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants.	up to 47 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): June 19, 2025
• Study Completion (Estimated): June 19, 2025

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ID110521156-T2DM-102

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
• product manufactured in and exported from the U.S.: No