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

NCT06635226 | Recruiting Phase 1 DMC

• 1 other identifier: ID110521156-T2DM-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• AEs/serious AEs (SAEs)

  Throughout study duration, up to 47 days

Secondary Outcomes (16)

• Maximum concentration of drug in plasma (Cmax)

  Day 1 and Day 28

• Area under the plasma drug concentration-time curve during a dosing interval (AUCtau)

  Day 1 and Day 28

• The time of peak concentration (Tmax)

  Day 1 and Day 28

• Terminal half-life (t1/2)

  Day 1 and Day 28

• Apparent clearance (CL/F)

  Day 1 and Day 28

Study Arms (3)

Cohort 1

EXPERIMENTAL

Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)

Drug: ID110521156; Drug: Placebo of 110521156

Cohort 2

EXPERIMENTAL

Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)

Drug: ID110521156; Drug: Placebo of 110521156

Cohort 3

EXPERIMENTAL

Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)

Drug: ID110521156; Drug: Placebo of 110521156

Interventions

ID110521156 DRUG

ID110521156 capsules taken orally once daily

Cohort 1; Cohort 2; Cohort 3

Placebo of 110521156 DRUG

ID110521156 placebo capsules taken orally once daily

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 ≥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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Central Study Contacts

Clinical Ops Study Leader

CONTACT

+82-10-4570-1405; eh.hong@yunovia.com

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: October 2, 2024
• First Posted: October 10, 2024
• Study Start: November 13, 2024
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

KR (1)