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

IlDong Pharmaceutical logo

IlDong Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy Adult Subjects

Treatments

Drug: ID110521156
Drug: Placebo of ID110521156

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT06063291
ID110521156-T2DM-101

Details and patient eligibility

About

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.

Enrollment

36 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 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

36 participants in 4 patient groups

Cohort 1
Experimental group
Description:
Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Treatment:
Drug: Placebo of ID110521156
Drug: ID110521156
Cohort 2
Experimental group
Description:
Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Treatment:
Drug: Placebo of ID110521156
Drug: ID110521156
Cohort 3
Experimental group
Description:
Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Treatment:
Drug: Placebo of ID110521156
Drug: ID110521156
Cohort 4
Experimental group
Description:
Cohort 4 will consist of 12 healthy subjects who will receive a single oral dose of ID110521156 at fed state and fasted state each.
Treatment:
Drug: ID110521156

Trial contacts and locations

1

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Central trial contact

Clinical Ops Study Leader

Data sourced from clinicaltrials.gov

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