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Completed

NCT Number: NCT06063291

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

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.

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Key information

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. AEs/serious AEs (SAEs)

    Time frame: Throughout study duration, up to 9 days

    Incidence and severity of ad adverse event

  2. 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

  1. Maximum concentration (Cmax)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

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

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

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

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

  4. The time of peak concentration,(Tmax)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

  5. Terminal half-life (T1/2)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

  6. Apparent clearance (CL/F)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

  7. Apparent volume of distribution after extravascular administration (Vd/F)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

  8. Amount excreted in urine (Ae)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

  9. Renal Clearance (CLr)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

  10. Fraction excreted unchanged of an administered dose (fe)

    Time frame: Throughout study duration, up to 9 days

    Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Collaborators

  • YUNOVIA CO.,LTD.

Registry information

Official study title

A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics After a Single Oral Administration of ID110521156 in Healthy Subjects

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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