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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects

NCT ID: NCT06635226

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2025-06-19

Brief Summary

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

Detailed Description

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Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)

Group Type EXPERIMENTAL

ID110521156

Intervention Type DRUG

ID110521156 capsules taken orally once daily

Placebo of 110521156

Intervention Type DRUG

ID110521156 placebo capsules taken orally once daily

Cohort 2

Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)

Group Type EXPERIMENTAL

ID110521156

Intervention Type DRUG

ID110521156 capsules taken orally once daily

Placebo of 110521156

Intervention Type DRUG

ID110521156 placebo capsules taken orally once daily

Cohort 3

Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)

Group Type EXPERIMENTAL

ID110521156

Intervention Type DRUG

ID110521156 capsules taken orally once daily

Placebo of 110521156

Intervention Type DRUG

ID110521156 placebo capsules taken orally once daily

Interventions

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ID110521156

ID110521156 capsules taken orally once daily

Intervention Type DRUG

Placebo of 110521156

ID110521156 placebo capsules taken orally once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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YUNOVIA CO.,LTD.

UNKNOWN

Sponsor Role collaborator

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Clinical Ops Study Leader

Role: CONTACT

Phone: +82-10-4570-1405

Email: [email protected]

Facility Contacts

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Seunghwan Lee

Role: primary

Other Identifiers

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ID110521156-T2DM-102

Identifier Type: -

Identifier Source: org_study_id