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

NCT ID: NCT06063291

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2024-07-11

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.

Conditions

Healthy Adult Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.

Group Type: EXPERIMENTAL

ID110521156

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Cohort 2

Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.

Group Type: EXPERIMENTAL

ID110521156

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Cohort 3

Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.

Group Type: EXPERIMENTAL

ID110521156

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

ID110521156

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

YUNOVIA CO.,LTD.

UNKNOWN

Sponsor Role: collaborator

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ID110521156-T2DM-101

Identifier Type: -

Identifier Source: org_study_id