Healthy Subjects
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.
Interventions
Sponsors
Gan and Lee Pharmaceuticals, USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Voluntarily participated in the study and signed the informed consent form (ICF); * 2\. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF; * 3.Body mass index \[BMI= weight (kg)/height (m) 2\] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；
Exclusion criteria
* 1\. Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG; * 2\. Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study; * 3\. Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test; * 4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening; * 5\. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AE) | From Predose to Day14 after a single dose | Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GIRmax | From 0 hours to 24 hours after a single dose | Maximum glucose infusion rate |
| AUCGZR33,0-24 h | From Predose to Day8 after a single dose | Area under the plasma concentration curve of GZR33 from 0 to 24 hours |
| AUCIAsp，0-12 h | From 0 hours to 12 hours after a single dose | Area under the plasma concentration curve of insulin aspart from 0 to 12 hours |
Countries
China
Outcome results
None listed