Clinical trial NCT06063291: Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects
Official title: A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics After a Single Oral Administration of ID110521156 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: YUNOVIA CO.,LTD.
First posted: 2023-10-02
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 and pharmacokinetics of single oral doses of ID110521156 in healthy adult subjects. This is the first clinical study of ID110521156.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: AEs/serious AEs (SAEs)
timeFrame: Throughout study duration, up to 9 days
measure: Percentage of subjects with clinically significant change from baseline in vital signs, ECG, safety laboratory test results
timeFrame: Throughout study duration, up to 9 days
Secondary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Throughout study duration, up to 9 days
measure: Area under the plasma drug concentration-time curve from 0 to last, (AUClast)
timeFrame: Throughout study duration, up to 9 days
measure: Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)
timeFrame: Throughout study duration, up to 9 days
measure: The time of peak concentration,(Tmax)
timeFrame: Throughout study duration, up to 9 days
measure: Terminal half-life (T1/2)
timeFrame: Throughout study duration, up to 9 days
measure: Apparent clearance (CL/F)
timeFrame: Throughout study duration, up to 9 days
measure: Apparent volume of distribution after extravascular administration (Vd/F)
timeFrame: Throughout study duration, up to 9 days
measure: Amount excreted in urine (Ae)
timeFrame: Throughout study duration, up to 9 days
measure: Renal Clearance (CLr)
timeFrame: Throughout study duration, up to 9 days
measure: Fraction excreted unchanged of an administered dose (fe)
timeFrame: Throughout study duration, up to 9 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: