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Active not recruitingPhase 1

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

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 SAERelative bioavailability of GZR18 tabletADA 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

NCT IDNCT06554054
Org study IDGL-GLP-CH1010

Timeline

Milestones

Study start2024-04-01actual
Study first posted2024-08-14actual
Last update posted2024-08-14actual
Primary completion2024-12-09estimated
Study completion2024-12-09estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint

AE and SAE

Time frame:22 days and 35 days

descriptive

Primary/protocol endpoint

Relative bioavailability of GZR18 tablet

Time frame:22 days and 35 days

descriptive

Primary/protocol endpoint

ADA and NAb

Time frame:22 days and 35 days

descriptive

Secondary/protocol endpoint

Cmax

Time frame:22 days and 35 days

concentration, descriptive

Secondary/protocol endpoint

AUC0-t

Time frame:22 days and 35 days

descriptive

Secondary/protocol endpoint

AUC0-24h

Time frame:22 days and 35 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.