A Phase I Study of GZR18 Injection in Healthy Subjects

NCT ID: NCT06548997

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2022-10-20

Brief Summary

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.

Conditions

Type 2 Diabetes; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GZR18

Group Type: EXPERIMENTAL

GZR18

Intervention Type: DRUG

5 μg/kg-maximum tolerated dose (MTD), single dose or two doses

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

administered the same volume as GZR18

Interventions

GZR18

5 μg/kg-maximum tolerated dose (MTD), single dose or two doses

Intervention Type: DRUG

Placebo

administered the same volume as GZR18

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liyuan Zhao, Ph.D

Role: STUDY_DIRECTOR

Gan & Lee Pharmaceuticals.

Locations

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, , China

Countries

China

Other Identifiers

GL-GLP-CH1002

Identifier Type: -

Identifier Source: org_study_id