A Phase I Study of GZR18 Injection in Healthy Subjects

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose

This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.

Inclusion Criteria:

• 1. Subjects sign informed consent voluntarily.
• 2. Chinese adult subjects, male or female.
• 3. Age 18-55 at screening (both included).
• 4. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
• 5. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.

Exclusion Criteria:

• 1. History of dizziness with blood and needles.
• 2. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
• 3. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
• 4. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
• 5. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
• 6. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.