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

Recruiting
19 - 50 years of age
Both
Phase 1

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Overview

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult sbujects. This is the first clinical study of ID110521156.

Eligibility

Inclusion Criteria:

  • Healthy subjects aged 19 to 55 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 hasbeen 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 (includingdrug 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 forthe duration of the study and for at least 3 months after the last dose.

Study details

Healthy Adult Subjects

NCT06063291

IlDong Pharmaceutical Co Ltd

3 May 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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