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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663879
• Other study ID #: ID120040002-GERD-101
• Status: Recruiting
• Phase: Phase 1
• Start date: December 7, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: December 2022
• Source: IlDong Pharmaceutical Co Ltd
• Contact: Mi Yeoun Lee
• Phone: 02-526-3114
• Email: mylee22[@]ildong.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ID120040002
Drug: ID120040002
• Compound-X
Drug: Compound-X
• Placebo comparator
Placebo comparator

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)