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

NCT05663879 | Unknown Phase 1

• 1 other identifier: ID120040002-GERD-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (10)

ID120040002 A mg

EXPERIMENTAL

Single dose 8 volunteers will be administered ID120040002 Amg or placebo comparators (ID120040002: placebo = 6:2)

Drug: ID120040002; Drug: Placebo comparator

ID120040002 Bmg

EXPERIMENTAL

Single dose 8 volunteers will be administered ID120040002 Bmg or placebo comparators (ID120040002: placebo = 6:2)

Drug: ID120040002; Drug: Placebo comparator

ID120040002 Cmg

EXPERIMENTAL

Single dose 8 volunteers will be administered ID120040002 Cmg or placebo comparators (ID120040002: placebo = 6:2)

Drug: ID120040002; Drug: Placebo comparator

ID120040002 Dmg

EXPERIMENTAL

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: Placebo comparator

ID120040002 Emg

EXPERIMENTAL

Single dose 8 volunteers will be administered ID120040002 Emg or placebo comparators (ID120040002: placebo = 6:2)

Drug: ID120040002; Drug: Placebo comparator

ID120040002 Fmg

EXPERIMENTAL

Multiple dose 10 volunteers will be administered ID120040004 F mg or placebo comparators (ID120040002: placebo: 8:2)

Drug: ID120040002; Drug: Placebo comparator

ID120040002 Gmg

EXPERIMENTAL

Multiple dose 10 volunteers will be administered ID120040004 G mg or placebo comparators (ID120040002: placebo: 8:2)

Drug: ID120040002; Drug: Placebo comparator

ID120040002 Hmg

EXPERIMENTAL

Multiple dose 10 volunteers will be administered ID120040004 H mg or placebo comparators (ID120040002: placebo: 8:2)

Drug: ID120040002; Drug: Placebo comparator

ID120040002 Img

EXPERIMENTAL

Multiple dose 10 volunteers will be administered ID120040004 I mg or placebo comparators (ID120040002: placebo: 8:2)

Drug: ID120040002; Drug: Placebo comparator

Compound-X Jmg

ACTIVE COMPARATOR

Multiple dose 8 volunteers will be administered compound-X J mg

Drug: Compound-X

Interventions

ID120040002 DRUG

Drug: ID120040002

ID120040002 A mg; ID120040002 Bmg; ID120040002 Cmg; ID120040002 Dmg; ID120040002 Emg; ID120040002 Fmg; ID120040002 Gmg; ID120040002 Hmg; ID120040002 Img

Compound-X DRUG

Drug: Compound-X

Compound-X Jmg

Placebo comparator DRUG

Placebo comparator

ID120040002 A mg; ID120040002 Bmg; ID120040002 Cmg; ID120040002 Dmg; ID120040002 Emg; ID120040002 Fmg; ID120040002 Gmg; ID120040002 Hmg; ID120040002 Img

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Study Officials

• SeungHwan Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi Yeoun Lee

CONTACT

02-526-3114; mylee22@ildong.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 23, 2022
• Study Start: December 7, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

KR (1)