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Recruiting NCT05663879

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

Conditions: Healthy

Sex: All
Ages: 19 Years – 50 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 86
Sponsor: IlDong Pharmaceutical Co Ltd

Location: Korea, Republic of

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

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/m2Subjects who have decided to voluntarily participate and consented in writing to comply with the precautions after listening to a detailed explanation of this clinical studySubjects 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 productSubjects 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 diseasesSubjects who have received H. pylori eradication therapy within 6 months, or have positive result for H. pylori test at screening

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05663879). StuddyBuddy aggregates publicly available trial information.