A Study of GZR18 Tablet in Chinese Healthy Subjects

NCT06554054 | Active Not Recruiting Phase 1

• 1 other identifier: GL-GLP-CH1010
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Cmax

  22 days and 35 days

• AUC0-t

  22 days and 35 days

• AUC0-24h

  22 days and 35 days

Study Arms (2)

Experimental: Part A (single dose)

EXPERIMENTAL

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

Experimental: Part B (multiple dose)

EXPERIMENTAL

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

Drug: GZR18

Interventions

GZR18 DRUG

Oral administered the GZR18 tablet

Experimental: Part A (single dose); Experimental: Part B (multiple dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects sign informed consent voluntarily.
• Age 18-55 at screening (both included)，male or female（male only for part A）.
• At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.
• Female subjects were HCG negative at screening and baseline

You may not qualify if:

• Female subjects who are pregnant or lactating at screening.
• History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.
• Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.
• 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.
• Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Study Site 01

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xiao Min, Ph.D

  Gan & Lee Pharmaceuticals Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: April 1, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CN (1)