Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063291
• Other study ID #: ID110521156-T2DM-101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 20, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: April 2024
• Source: IlDong Pharmaceutical Co Ltd
• Contact: Clinical Ops Study Leader
• Phone: 82-2-526-3386
• Email: wonkyung.lee[@]yunovia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult sbujects. This is the first clinical study of ID110521156.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy subjects aged 19 to 55 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 hasbeen 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 (includingdrug 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 forthe duration of the study and for at least 3 months after the last dose.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• ID110521156
subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1
• Placebo of ID110521156
subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd	YUNOVIA CO.,LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs/serious AEs (SAEs)	Incidence and severity of ad adverse event	Throughout study duration, up to 9 days
Primary	Percentage of subjects with clinically significant change from baselin in vital signs, ECG, safety laboratory test restuls		Throughout study duration, up to 9 days
Secondary	Maximum concentration (Cmax)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Area under the plasma drug concentration-time curve from 0 to last, (AUClast)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	The time of peak concentration,(Tmax)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Terminal half-life (T1/2)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Apparent clearance (CL/F)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Apparent volume of distribution after extravascular administration (Vd/F)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Amount excreted in urine (Ae)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Renal Clearance (CLr)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days
Secondary	Fraction excreted unchanged of an administered dose (fe)	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156	Throughout study duration, up to 9 days