A Study of GZR18 Tablet in Chinese Healthy Subjects

Phase 1

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: GZR18

• Registration Number: NCT06554054
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Part A (single dose)	GZR18	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).
Experimental: Part B (multiple dose)	GZR18	Drug:GZR18 tablet GZR18 tablet administered as two multiple dose cohorts, to test the different meal time effect. Parallel assignment

Primary Outcome Measures

Name	Time	Method
Relative bioavailability of GZR18 tablet	22 days and 35 days	Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%
ADA and NAb	22 days and 35 days	Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
AE and SAE	22 days and 35 days	Incidence of Adverse Events and Severe Adverse Events

Secondary Outcome Measures

Name	Time	Method
Cmax	22 days and 35 days	Maximum plasma drug concentration
AUC0-t	22 days and 35 days	Area under the curve from 0 through the time of the last accurately measurable concentration
AUC0-24h	22 days and 35 days	Area under the curve from 0 h to 24 hours

Trial Locations

Locations (1)

Study Site 01; 🇨🇳 Beijing, China