Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects

Launched by ILDONG PHARMACEUTICAL CO LTD · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called ID110521156 to see how safe it is and how the body absorbs and processes it. The study is specifically looking for healthy adults aged between 19 and 50 years who have a body mass index (BMI) of 27 or higher. To participate, individuals must not have any significant health issues and must not be pregnant or breastfeeding. The trial is currently recruiting participants, and both men and women are welcome to sign up.

If you choose to take part in this study, you will be given multiple doses of the medication to evaluate how well your body tolerates it. The researchers will monitor you closely throughout the trial to ensure your safety. It's important to note that if you're a man, you will need to agree to use effective birth control during the study and for a short period afterward. This study is a valuable step in understanding how this new treatment may work for future patients.

Gender

ALL

Eligibility 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.