Actively Recruiting
Study of Safety, Tolerability, and Body Effects of Oral ID110521156 in Healthy Adults A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Clinical Trial
Led by IlDong Pharmaceutical Co Ltd · Updated on 2024-12-24
36
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
I
IlDong Pharmaceutical Co Ltd
Lead Sponsor
Y
YUNOVIA CO.,LTD.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of a drug called ID110521156 in healthy adults aged 19 to 50 years. This phase 1 clinical trial aims to understand how the drug behaves in the body and its effects when taken daily. The study includes healthy volunteers without significant medical conditions to ensure accurate assessment of the drug's profile. Participants will receive either ID110521156 capsules or matching placebo capsules taken orally once daily. The study design is randomized, double-blinded, and placebo-controlled to compare the effects of the active drug versus placebo. Multiple ascending doses will be tested to evaluate safety and tolerability across different dose levels. During the study, participants will be closely monitored for any adverse events or serious adverse events throughout a period of up to 47 days. Researchers will assess the drug's safety, how the body processes the drug, and its biological effects. Participants will provide informed consent and undergo regular health assessments to ensure their well-being during the trial.
CONDITIONS
Official Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy subjects aged 19 to 50 years at the time of Screening.
- Body mass index (BMI) within 6527 kg/m2; and a total body weight 65 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).
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
C
Clinical Ops Study Leader
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Frequently Asked Questions
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