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

NCT06635226 — Phase 1, Recruiting, 36 participants, IlDong Pharmaceutical Co Ltd

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

RegistryNCT06635226
StatusRecruiting
PhasePhase 1
Study typeInterventional; randomized, sequential, masking: double, basic science
Enrollment36 (Estimated)
SponsorIlDong Pharmaceutical Co Ltd (Industry); collaborators: YUNOVIA CO.,LTD.
ConditionsHealthy Adult Subjects
InterventionsID110521156, Placebo of 110521156 (Drug)
Datesstart 2024-11-13, primary completion 2025-06-19 (estimated), completion 2025-06-19 (estimated), first posted 2024-10-10, last updated 2024-12-24
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Adult Subjects All trials of ID110521156 All trials of Placebo of 110521156

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Cohort 1ExperimentalDrug: ID110521156; Drug: Placebo of 110521156Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Cohort 2ExperimentalDrug: ID110521156; Drug: Placebo of 110521156Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Cohort 3ExperimentalDrug: ID110521156; Drug: Placebo of 110521156Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
  • ID110521156 (Drug): ID110521156 capsules taken orally once daily
  • Placebo of 110521156 (Drug): ID110521156 placebo capsules taken orally once daily

+Outcome measures

Primary outcomes

  • AEs/serious AEs (SAEs) [Throughout study duration, up to 47 days]

Secondary outcomes

  • Maximum concentration of drug in plasma (Cmax) [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Area under the plasma drug concentration-time curve during a dosing interval (AUCtau) [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • The time of peak concentration (Tmax) [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Terminal half-life (t1/2) [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Apparent clearance (CL/F) [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Apparent volume of distribution after extravascular administration (Vd/F) [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Renal clearance (CLR) [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • fe [Day 1 and Day 28]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Trough plasma concentration taken directly before the next dose (Ctrough) [Throughout study duration, up to 27 days]: To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Minimum concentration of drug in plasma at steady state (Cmin, ss) [Day 28]: To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
  • Average concentration of drug in plasma at steady state (Cavg, ss) [Day 28]: To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
  • peak to trough fluctuation (PTF) [Day 28]: To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
  • accumulation ratio (R) [Day 28]: To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
  • Serum glucose [up to 28 days]: To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Insulin [up to 28 days]: To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
  • Hemoglobin A1c (HbA1c) [up to 47 days]: To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants.

+Eligibility

Sex: All, ages: 19 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Seoul National University HospitalSeoulSouth KoreaRecruiting