A Study of GZR18 Tablet in Chinese Healthy Subjects

NCT ID: NCT06554054

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-12-09

Brief Summary

The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Part A (single dose)

Drug: GZR18 tablet Three single-dose cohorts of GZR18 tablet administered according to an ascending dose design. Progression to next dose will be based on safety evaluation. Sequential cohorts.

Active Comparator: GZR18 injection Single-dose administered s.c. (under the skin).

Group Type: EXPERIMENTAL

GZR18

Intervention Type: DRUG

Oral administered the GZR18 tablet

Experimental: Part B (multiple dose)

Drug:GZR18 tablet GZR18 tablet administered as two multiple dose cohorts, to test the different meal time effect.

Parallel assignment

Group Type: EXPERIMENTAL

GZR18

Intervention Type: DRUG

Oral administered the GZR18 tablet

Interventions

GZR18

Oral administered the GZR18 tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects sign informed consent voluntarily.

2. Age 18-55 at screening (both included)，male or female（male only for part A）.

3. At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.

4. Female subjects were HCG negative at screening and baseline

Exclusion Criteria

1. Female subjects who are pregnant or lactating at screening.

2. History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.

3. Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.

4. History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results.

5. Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao Min, Ph.D

Role: STUDY_DIRECTOR

Gan & Lee Pharmaceuticals Co., Ltd

Locations

Study Site 01

Beijing, , China

Countries

China

Other Identifiers

GL-GLP-CH1010

Identifier Type: -

Identifier Source: org_study_id