Status:
COMPLETED
Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects
Lead Sponsor:
IlDong Pharmaceutical Co Ltd
Collaborating Sponsors:
YUNOVIA CO.,LTD.
Conditions:
Healthy Adult Subjects
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult subjects. This is the first clinical study of ID110521156.
Eligibility Criteria
Inclusion
- Healthy subjects aged 19 to 50 years at the time of Screening.
- Body mass index (BMI) within 18.5 to 29.9 kg/m2; and a total body weight ≥ 40 kg, ≤ 90 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
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal(including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- Treatment with an investigational drug (including a bioequivalence study) within 6 months prior to the scheduled date of 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 3 months after the last dose.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06063291
Start Date
November 20 2023
End Date
July 11 2024
Last Update
November 25 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080