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

IlDong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Compound-X; Drug: Placebo comparator; Drug: ID120040002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05663879

ID120040002-GERD-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 10 patient groups

ID120040002 A mg

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Bmg

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Cmg

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Dmg

Experimental group

Description:

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)

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Emg

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Fmg

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Gmg

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Hmg

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

ID120040002 Img

Experimental group

Description:

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

Treatment:

Drug: ID120040002

Drug: Placebo comparator

Compound-X Jmg

Active Comparator group

Description:

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

Treatment:

Drug: Compound-X