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

NCT ID: NCT05663879

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-07

Study Completion Date

2023-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ID120040002 A mg

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

ID120040002 Bmg

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

ID120040002 Cmg

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

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)

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

ID120040002 Emg

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

ID120040002 Fmg

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

ID120040002 Gmg

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

ID120040002 Hmg

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

ID120040002 Img

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

Group Type EXPERIMENTAL

ID120040002

Intervention Type DRUG

Drug: ID120040002

Placebo comparator

Intervention Type DRUG

Placebo comparator

Compound-X Jmg

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

Group Type ACTIVE_COMPARATOR

Compound-X

Intervention Type DRUG

Drug: Compound-X

Interventions

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ID120040002

Drug: ID120040002

Intervention Type DRUG

Compound-X

Drug: Compound-X

Intervention Type DRUG

Placebo comparator

Placebo comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SeungHwan Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Mi Yeoun Lee

Role: CONTACT

Phone: 02-526-3114

Email: [email protected]

Facility Contacts

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SeungHwan Lee, MD, PhD

Role: primary

Other Identifiers

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ID120040002-GERD-101

Identifier Type: -

Identifier Source: org_study_id