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

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Drug: ID110521156; Drug: Placebo of ID110521156

• Registration Number: NCT06063291
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-02
• Study Start: 2023-11-20
• Primary Completion: 2024-07-11
• Study Completion: 2024-07-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Placebo of ID110521156	Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Cohort 3	ID110521156	Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Cohort 1	ID110521156	Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Cohort 1	Placebo of ID110521156	Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Cohort 3	Placebo of ID110521156	Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Cohort 2	ID110521156	Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Cohort 4	ID110521156	Cohort 4 will consist of 12 healthy subjects who will receive a single oral dose of ID110521156 at fed state and fasted state each.

Primary Outcome Measures

Name	Time	Method
AEs/serious AEs (SAEs)	Throughout study duration, up to 9 days	Incidence and severity of ad adverse event
Percentage of subjects with clinically significant change from baseline in vital signs, ECG, safety laboratory test results	Throughout study duration, up to 9 days

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Terminal half-life (T1/2)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
The time of peak concentration,(Tmax)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Apparent clearance (CL/F)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Area under the plasma drug concentration-time curve from 0 to last, (AUClast)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Apparent volume of distribution after extravascular administration (Vd/F)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Amount excreted in urine (Ae)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Fraction excreted unchanged of an administered dose (fe)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Renal Clearance (CLr)	Throughout study duration, up to 9 days	Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of