Clinical trial NCT06635226: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: YUNOVIA CO.,LTD.
First posted: 2024-10-10
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.


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.

Primary outcomes:
measure: AEs/serious AEs (SAEs)
timeFrame: Throughout study duration, up to 47 days
Secondary outcomes:
measure: Maximum concentration of drug in plasma (Cmax)
timeFrame: Day 1 and Day 28
measure: Area under the plasma drug concentration-time curve during a dosing interval (AUCtau)
timeFrame: Day 1 and Day 28
measure: The time of peak concentration (Tmax)
timeFrame: Day 1 and Day 28
measure: Terminal half-life (t1/2)
timeFrame: Day 1 and Day 28
measure: Apparent clearance (CL/F)
timeFrame: Day 1 and Day 28
measure: Apparent volume of distribution after extravascular administration (Vd/F)
timeFrame: Day 1 and Day 28
measure: Renal clearance (CLR)
timeFrame: Day 1 and Day 28
measure: fe
timeFrame: Day 1 and Day 28
measure: Trough plasma concentration taken directly before the next dose (Ctrough)
timeFrame: Throughout study duration, up to 27 days
measure: Minimum concentration of drug in plasma at steady state (Cmin, ss)
timeFrame: Day 28
measure: Average concentration of drug in plasma at steady state (Cavg, ss)
timeFrame: Day 28
measure: peak to trough fluctuation (PTF)
timeFrame: Day 28
measure: accumulation ratio (R)
timeFrame: Day 28
measure: Serum glucose
timeFrame: up to 28 days
measure: Insulin
timeFrame: up to 28 days
measure: Hemoglobin A1c (HbA1c)
timeFrame: up to 47 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: