A Phase I Study of GZR18 Injection in Healthy Subjects

NCT06548997 | Completed Phase 1

• 1 other identifier: GL-GLP-CH1002
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• TEAE

  Incidence of treatment-emergent adverse events (TEAE)

  after 28/35 days of treatment

Secondary Outcomes (16)

• Cmax

  28/35 days

• AUClast

  28/35 days

• AUC0-inf

  28/35 days

• Tmax

  28/35 days

• λz

  28/35 days

Study Arms (2)

GZR18

EXPERIMENTAL

Drug: GZR18

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

GZR18 DRUG

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

GZR18

Placebo OTHER

administered the same volume as GZR18

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. History of dizziness with blood and needles.
• \. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
• \. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
• \. 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.
• \. 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).
• \. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liyuan Zhao, Ph.D

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: December 2, 2021
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CN (1)