Status:
ACTIVE_NOT_RECRUITING
A Study of GZR18 Tablet in Chinese Healthy Subjects
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06554054
Start Date
April 1 2024
End Date
December 9 2024
Last Update
August 14 2024
Active Locations (1)
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1
Study Site 01
Beijing, China