A Study of GZR18 Tablet in Chinese Healthy Subjects

Gan and Lee Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: GZR18

Study type: Interventional

Funder types: Industry

Identifiers

NCT06554054

GL-GLP-CH1010

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Experimental: Part A (single dose)

Experimental group

Description:

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).

Treatment:

Drug: GZR18

Experimental: Part B (multiple dose)

Experimental group

Description:

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

Treatment:

Drug: GZR18