Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects

NCT05328726 | Completed Phase 1 FDA Drug

• 1 other identifier: GL-GLP-1012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single ascending dose first time in human study for GZR18 in healthy subjects

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  The primary outcome for this study is Dose Limiting Toxicity, which is the composite of any SAE, any pancreatitis(as measured by amylase) or renal dysfunction (as measured by serum creatinine)

  Up to 31 days

Secondary Outcomes (2)

• Maximum Plasma Concentration

  Up to 720 hours

• Glycosylated Hemoglobin

  Up to 720 hours

Study Arms (2)

Drug:GZR-18 administered via subcutaneous injection

EXPERIMENTAL

For Assigned Interventions: GZR-18 administered once via subcutaneous injection at doses of 1.0 ug/kg, 5.0 ug/kg, 10.0 ug/kg, 20.0 ug/kg, 30.0 ug/kg, 40.0 ug/kg \& 50.0 ug/kg

Drug: GZR-18

Placebo control

PLACEBO COMPARATOR

Commercially obtained sterile, normal saline for injection will be used as the matching placebo. Placebo will be dosed in an identical manner to active study drug. The volume of placebo will be calculated according to body weight using active drug dose for volume calculation in order to maintain the study blind.

Other: Placebo

Interventions

GZR-18 DRUG

As previously described in Arms

Drug:GZR-18 administered via subcutaneous injection

Placebo OTHER

Placebo will be dosed in an identical manner to active study drug.

Also known as: Placebo Control

Placebo control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign and date informed consent prior to any study-related activities being performed
• Be considered healthy in the opinion of the PI or qualified designee and have no clinically significant abnormal laboratory values at screening
• Male
• Aged 18 to 60 years, inclusive, at the time of signing the informed consent. Note: if the study is to be conducted at a clinical site located in Lincoln, Nebraska, the lower age limit will be 19 years of age
• Have a BMI between 20.0 to 35.0 kg/m2, inclusive, at Screening or check-in prior to dosing
• Have a normal renal function as defined by estimated glomerular filtration rate (eGFR) \> 90 mL/min/1.73m2 at Screening or check-in prior to dosing
• Be able to understand and comply with protocol requirements, instructions, and any protocol-stated restrictions

You may not qualify if:

• The Investigator or qualified designee considers the subject unfit for the study, based on medical interview, physical examination, or laboratory results. Individuals must be free from clinically significant illness or disease, as determined by the PI or qualified designee, with no clinically significant abnormality identified on the medical or laboratory evaluations, including 12-lead ECG
• Positive hepatitis-B surface antigen, positive hepatitis-C, or positive HIV test
• History of cholelithiasis or obstructive or inflammatory gallbladder disease within 3 months prior to screening
• Personal or family history of medullary cell carcinoma or multiple endocrine neoplasia syndrome type 2
• History of inadequately controlled thyroid disease, as reflected by an abnormal thyroid stimulating hormone test or free T4
• History of gastrointestinal surgical intervention for obesity
• History of chronic or acute pancreatitis
• History of significant drug or other allergy or hypersensitivity that, in the opinion of the Investigator or qualified designee, contraindicates the subject's participation in the study
• History of alcohol abuse, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is defined as equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine
• Unwilling to abstain from alcohol from 24 hours prior to the start of dosing until discharge from the clinic
• Smoked or used tobacco- or nicotine-containing products within the previous 6 months prior to Screening
• Treatment with an investigational drug or participated in any other interventional clinical study during the previous 30 days or within 5 half-lives after the last dose of the investigational drug, whichever is longer. Note: 30-day/5-half-life washout is defined as last dose of investigational drug in the previous study until the first screening visit in the current study
• Unwilling to refrain from the use of illicit drugs and unwilling to ad-here to other protocol-stated restrictions while participating in the study
• Unwilling to abstain from caffeine- or xanthine-containing products from 24 hours prior to dosing until discharge from the clinic
• A positive drug and alcohol screen at screening or check-in prior to dosing

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kimberly Lazaroff, MSN

  Gan and Lee Pharmaceuticals, USA Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Enrollment of up to 56 subjects in up to 7 cohorts may occur. Randomization is 3:1 (active drug:placebo) across all cohorts. Within each cohort, 6 subjects will be randomized to receive GZR18, and 2 subjects will be randomized to receive placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a double-blinded, randomized, placebo-controlled, sequential, dose-escalating, single-dose study.

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: April 14, 2022
• Study Start: March 8, 2022
• Primary Completion: February 9, 2023
• Study Completion: March 9, 2023
• Last Updated: March 23, 2023

Record last verified: 2022-02

Locations

US (1)