A Study of GZR18 Tablet in Chinese Healthy Subjects

A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy Adult Subjects

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: GZR18

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Study site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: GZR18; Oral administered the GZR18 tablet
Experimental: 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	Drug: GZR18; Oral administered the GZR18 tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA
• Investigators: Study Director: Xiao Min, Ph.D, Gan & Lee Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 9, 2024
• Study Completion (Estimated): December 9, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GL-GLP-CH1010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No