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

Sponsor

IlDong Pharmaceutical Co Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05663879

Collaborator

(none)

Enrollment

Location

Arms

7.8

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ID120040002 Drug: Compound-X Drug: Placebo comparator	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 7, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of participants with Serious Adverse Events (SAEs) [From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)]
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Number of participants with Adverse Events (AEs) [From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)]
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

IlDong Pharmaceutical Co Ltd

Investigators

Principal Investigator: SeungHwan Lee, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IlDong Pharmaceutical Co Ltd

ClinicalTrials.gov Identifier:

NCT05663879

Other Study ID Numbers:

ID120040002-GERD-101

First Posted:

Dec 23, 2022

Last Update Posted:

Dec 23, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 23, 2022