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

IlDong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: Placebo of 110521156; Drug: ID110521156

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06635226

ID110521156-T2DM-102

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: ID110521156

Drug: Placebo of 110521156

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: ID110521156

Drug: Placebo of 110521156

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: ID110521156

Drug: Placebo of 110521156