CompletedNCT06063291Updated Nov 25, 2024

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

A Phase 1 interventional study of ID110521156 and Placebo of ID110521156 in Healthy Adult Subjects, sponsored by IlDong Pharmaceutical Co Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by IlDong Pharmaceutical Co Ltd · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 19 Years to 50 Years
Sex: All

Study 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.

Conditions studied

Healthy Adult Subjects

In context

Lead sponsor

IlDong Pharmaceutical Co Ltd is the lead sponsor of 49 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 36 participants (actual)

Study arms

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

Interventions

DrugID110521156
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
DrugPlacebo 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

What researchers measure

Primary outcomes

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

Secondary outcomes

Maximum concentration (Cmax)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Time frame: Throughout study duration, up to 9 days
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
Time frame: Throughout study duration, up to 9 days
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
Time frame: Throughout study duration, up to 9 days
The time of peak concentration,(Tmax)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Time frame: Throughout study duration, up to 9 days
Terminal half-life (T1/2)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Time frame: Throughout study duration, up to 9 days
Apparent clearance (CL/F)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Time frame: Throughout study duration, up to 9 days
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
Time frame: Throughout study duration, up to 9 days
Amount excreted in urine (Ae)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Time frame: Throughout study duration, up to 9 days
Renal Clearance (CLr)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Time frame: Throughout study duration, up to 9 days
Fraction excreted unchanged of an administered dose (fe)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Time frame: Throughout study duration, up to 9 days

Study locations

1 site

Seoul National University Hospital
Seoul, 03080, Korea, Republic of

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06063291
Lead sponsor: IlDong Pharmaceutical Co Ltd
Collaborators: YUNOVIA CO.,LTD.
Responsible party: Sponsor
First posted: Oct 2, 2023
Start date: Nov 20, 2023
Primary completion: Jul 11, 2024
Completion: Jul 11, 2024
Last update: Nov 25, 2024

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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