A Randomized, Double-blinded, Placebo-controlled, Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administrations of ID110521156 in Healthy Subjects
| Registry | NCT06635226 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, sequential, masking: double, basic science |
| Enrollment | 36 (Estimated) |
| Sponsor | IlDong Pharmaceutical Co Ltd (Industry); collaborators: YUNOVIA CO.,LTD. |
| Conditions | Healthy Adult Subjects |
| Interventions | ID110521156, Placebo of 110521156 (Drug) |
| Dates | start 2024-11-13, primary completion 2025-06-19 (estimated), completion 2025-06-19 (estimated), first posted 2024-10-10, last updated 2024-12-24 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Adult Subjects All trials of ID110521156 All trials of Placebo of 110521156
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1 | Experimental | Drug: ID110521156; Drug: Placebo of 110521156 | Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
| Cohort 2 | Experimental | Drug: ID110521156; Drug: Placebo of 110521156 | Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
| Cohort 3 | Experimental | Drug: ID110521156; Drug: Placebo of 110521156 | Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
Sex: All, ages: 19 Years to 50 Years, accepts healthy volunteers
Inclusion Criteria: * Healthy subjects aged 19 to 50 years at the time of Screening. * Body mass index (BMI) within ≥27 kg/m2; and a total body weight ≥ 50 kg * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study * For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc). Exclusion Criteria: * Evidence or history of clinically significant hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies. * Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product. * Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose.
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea | Recruiting |