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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Overweight and Obesity
• Intervention / Treatment: Other: Placebo; Drug: GZR18

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Gan & Lee Pharmaceuticals Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; administered the same volume as GZR18
Experimental: GZR18	Drug: GZR18; 5 μg/kg-maximum tolerated dose (MTD), single dose or two doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAE	Incidence of treatment-emergent adverse events (TEAE)	after 28/35 days of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA
• Investigators: Study Director: Liyuan Zhao, Ph.D, Gan & Lee Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: GL-GLP-CH1002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No