Healthy Subjects
Conditions
Brief summary
This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B. Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection. Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.
Interventions
DRUGGZR33 Injection
Administered as once daily subcutaneous dose
DRUGGZR101 Injection
Administered as once daily subcutaneous dose
DRUGPlacebo
Administered as once daily subcutaneous dose
DRUGInsulin Degludec
Administered as once daily subcutaneous dose
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 (including 18 and 45 years old as of the date of signing the ICF); * 3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight\>50 kg (not containing 50kg).
Exclusion criteria
* 1.History of drug abuse within one year prior to screening. * 2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period. * 3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance. * 4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive. * 5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24h | From 0 to 24 hours | Area under the plasma concentration-time curve from time 0 to 24 hours |
| Incidence of adverse events (AE) | From Predose to Day12 | 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 |
|---|---|---|
| Cmax | From Predose to Day7 | Maximum plasma concentration |
| tmax | From Predose to Day7 | Time to reach maximum plasma concentration |
| AUC0-last | From Predose to Day7 | Area under the plasma concentration-time curve from time 0 to the last blood sampling time point |
Countries
China
Outcome results
None listed