Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of ID120040002 in Healthy Volunteers

Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers

A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo comparator; Drug: ID120040002; Drug: Compound-X

Detailed Description

To evaluate the safety, tolerability, and pharmacokinetic characteristics and to explore pharmacodynamic characteristics and food effects after single and multiple doses of ID120040002 in healthy volunteers.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mi Yeoun Lee; Phone Number: 02-526-3114; Email: mylee22@ildong.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: SeungHwan Lee, MD, PhD
    • Principal Investigator: SeungHwan Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who have a body weight of ≥50.0 kg to ≤90.0 kg, and Body Mass Index (BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2
• Subjects who have decided to voluntarily participate and consented in writing to comply with the precautions after listening to a detailed explanation of this clinical study
• Subjects who consent to use contraceptive methods* accepted in this trial with their partners and not to donate sperm until 90 days and eggs until 28 days after the administration of the last dose of the IP from the time of written consent.

Exclusion Criteria:

• Subjects with a history of clinically significant cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, urinary, musculoskeletal and psychological disorders or malignant tumor, or current active diseases (however, subjects may be enrolled if the disease is completely recovered and does not affect the current health status)
• Subjects with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, hypochlorhydria, achlorhydria, etc.) or gastrointestinal surgery (excluding simple appendectomy and herniotomy) that can affect the absorption of the investigational product
• Subjects who have received the therapy for peptic ulcer, esophageal disease or Zollinger-Ellison syndrome within 90 days prior to the administration of the IP, or have clinically suspected symptoms of such diseases
• Subjects who have received H. pylori eradication therapy within 6 months, or have positive result for H. pylori test at screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ID120040002 A mg; Single dose 8 volunteers will be administered ID120040002 Amg or placebo comparators (ID120040002: placebo = 6:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Bmg; Single dose 8 volunteers will be administered ID120040002 Bmg or placebo comparators (ID120040002: placebo = 6:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Cmg; Single dose 8 volunteers will be administered ID120040002 Cmg or placebo comparators (ID120040002: placebo = 6:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Dmg; Period1: Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2) Period2: Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Emg; Single dose 8 volunteers will be administered ID120040002 Emg or placebo comparators (ID120040002: placebo = 6:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Fmg; Multiple dose 10 volunteers will be administered ID120040004 F mg or placebo comparators (ID120040002: placebo: 8:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Gmg; Multiple dose 10 volunteers will be administered ID120040004 G mg or placebo comparators (ID120040002: placebo: 8:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Hmg; Multiple dose 10 volunteers will be administered ID120040004 H mg or placebo comparators (ID120040002: placebo: 8:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Experimental: ID120040002 Img; Multiple dose 10 volunteers will be administered ID120040004 I mg or placebo comparators (ID120040002: placebo: 8:2)	Drug: Placebo comparator; Placebo comparator; Drug: ID120040002; Drug: ID120040002
Active Comparator: Compound-X Jmg; Multiple dose 8 volunteers will be administered compound-X J mg	Drug: Compound-X; Drug: Compound-X

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Serious Adverse Events (SAEs)	To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.	From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Number of participants with Adverse Events (AEs)	To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.	From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Percentage of subjects with clinically significant change from baseline in vital signs		From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)		From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd
• Investigators: Principal Investigator: SeungHwan Lee, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ID120040002-GERD-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No