Clinical trial NCT05663879: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of ID120040002 in Healthy Volunteers
Official title: Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-23
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
measure: Number of participants with Adverse Events (AEs)
timeFrame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
measure: Percentage of subjects with clinically significant change from baseline in vital signs
timeFrame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
measure: Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
timeFrame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: