Evaluating the safety and effects of ID110521156 in healthy adults
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
This study tests how safe a new drug called ID110521156 is and how it works in healthy adults aged 19 to 50.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 19 Years to 50 Years |
| Sex | All |
| Sponsor | IlDong Pharmaceutical Co Ltd Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06635226 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects. Participants will receive either the investigational drug or a placebo to determine how the drug behaves in the body and its potential effects. The study will involve healthy adults aged 19 to 50 years with specific body weight and health criteria. The findings will help inform future research and potential therapeutic applications of ID110521156.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19 to 50 years with a BMI of 27 kg/m2 or higher.
Not a fit: Patients with significant health issues or those who have recently participated in other investigational drug studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of ID110521156, paving the way for its use in treating various conditions.
How similar studies have performed: Other studies evaluating similar pharmacological agents have shown promise, but the specific approach of this study is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Clinical Ops Study Leader
- Email: eh.hong@yunovia.com
- Phone: +82-10-4570-1405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.