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

NCT06063291 | Completed Phase 1 DMC

• 1 other identifier: ID110521156-T2DM-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AEs/serious AEs (SAEs)

  Incidence and severity of ad adverse event

  Throughout study duration, up to 9 days

• 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 Outcomes (10)

• Maximum concentration (Cmax)

  Throughout study duration, up to 9 days

• Area under the plasma drug concentration-time curve from 0 to last, (AUClast)

  Throughout study duration, up to 9 days

• Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)

  Throughout study duration, up to 9 days

• The time of peak concentration,(Tmax)

  Throughout study duration, up to 9 days

• Terminal half-life (T1/2)

  Throughout study duration, up to 9 days

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

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

Cohort 4

EXPERIMENTAL

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

ID110521156 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 1; Cohort 2; Cohort 3; Cohort 4

Placebo of ID110521156 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 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead
• YUNOVIA CO.,LTD.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 2, 2023
• Study Start: November 20, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

KR (1)