← Trials/Trial dossier/NCT06554054
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
Lead sponsor
Asset
GZR18
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
92
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI ≤24.9
Primary endpoints
•AE and SAE•Relative bioavailability of GZR18 tablet•ADA and NAb
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
6 endpointsAE and SAE
Time frame:22 days and 35 days
descriptive
Relative bioavailability of GZR18 tablet
Time frame:22 days and 35 days
descriptive
ADA and NAb
Time frame:22 days and 35 days
descriptive
Cmax
Time frame:22 days and 35 days
concentration, descriptive
AUC0-t
Time frame:22 days and 35 days
descriptive
AUC0-24h
Time frame:22 days and 35 days
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.