Healthy Person
Conditions
Brief summary
This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects
Interventions
BIOLOGICALIBI3035
IBI3035 administered subcutaneously(SC)
BIOLOGICALInsulin icodec Injection
Insulin icodec Injection administered subcutaneously(SC)
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
The following inclusion criteria must be met: 1. Healthy male adult subjects aged 18 to 45 years (including 18 and 45 years, based on the date of signing the informed consent form) of Chinese nationality; 2. Body Mass Index (BMI) between 19.0 and 24.0 kg/m2 (including both values) at screening, and weight ≥ 50 kg; 3. Normal glucose tolerance at screening \[3.9 mmol/L \< fasting blood glucose \< 6.1 mmol/L, and 2-hour post-glucose load blood glucose \< 7.8 mmol/L in the oral glucose tolerance test (OGTT)\]; normal insulin secretion function or abnormality without clinical significance as determined by the investigator \[confirmed by the insulin release test (IRT)\]; 4. Glycated hemoglobin ≤ 6.0% at screening; 5. Agree to take effective contraceptive measures during the study period and within 6 months after the last dose and have no plan to donate sperm; 6. Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the blood drug concentration-time curve from 0 to 168 hours | From 0 to 168 hours after administration |
| Area Under Curve Glucose Infusion Rate (AUCGIR) 0-168h | From 0 to 168 hours after administration |
Secondary
| Measure | Time frame |
|---|---|
| Area Under Curve (AUC0-84h) | From 0 to 84 hours after administration |
| Tmax | From 0 to 168 hours after administration |
| Glucose Infusion Rate (GIR) max | From 0 to 168 hours after administration |
| Area Under Curve Glucose Infusion Rate (AUCGIR) 24-48h | From 24 to 48 hours after administration |
| Adverse events (AE) | through study completion, an average of 16 weeks |
| The generation of Anti-drug antibodies (ADA) and Neutrolizing antibodies (NAb if required) | through study completion, an average of 16 weeks |
| Area Under Curve (AUC) 84-168h | From 84 to 168 hours after administration |
| Cmax | From 0 to 168 hours after administration |
| T1/2 | From 0 to 168 hours after administration |
| tGIRmax | From 0 to 168 hours after administration |
| AUCGIR 144-168h | From 144 to 168 hours after administration |
| vital signs (Body temperature) | through study completion, an average of 16 weeks |
| laboratory tests (fasting plasma glucose (GLU)) | through study completion, an average of 16 weeks |
| 12-lead Electrocardiogram (RR interval, PR interval, heart rate (HR), QRS interval, QT interval, QTcF (QTcF = QT/RR^0.33)) | through study completion, an average of 16 weeks |
| vital signs (pulse) | through study completion, an average of 16 weeks |
| vital signs (respiratory rate) | through study completion, an average of 16 weeks |
| vital signs (blood pressure: systolic, diastolic) | through study completion, an average of 16 weeks |
Countries
China
Contacts
CONTACTShanyu Xu
Outcome results
None listed