A Phase I Study of GZR18 Injection in Healthy Subjects

Phase 1

Completed

• Conditions: Overweight and Obesity; Type 2 Diabetes
• Interventions: Drug: GZR18; Other: Placebo

• Registration Number: NCT06548997
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-02
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-20
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GZR18	GZR18	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
TEAE	after 28/35 days of treatment	Incidence of treatment-emergent adverse events (TEAE)

Secondary Outcome Measures

Name	Time	Method
AUClast	28/35 days	the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured
tlag	28/35 days	retention time
CL/F	28/35 days	apparent clearance rate
AUC0-inf	28/35 days	the area under the concentration-time curve from 0 to infinity
AUC%extra	28/35 days	extrapolation percentage of AUC0-in
AUCglucose0-14h	28/35 days	area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration
AUCinsulin0-14h	28/35 days	area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration
body weight	28/35 days
Cmax	28/35 days	The peak concentration after reaching the target dose
Vz/F	28/35 days	apparent volume of distribution
MRT	28/35 days	average retention time
λz	28/35 days	the elimination rate constant
Tmax	28/35 days	the peak time
t1/2	28/35 days	the half-life
AUCc-peptide0-14h	28/35 days	area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration
body mass index (BMI）	28/35 days

Trial Locations

Locations (1)

Gan & Lee Pharmaceuticals Co., Ltd; 🇨🇳 Beijing, China