Healthy Participants
Conditions
Brief summary
This open-label, randomized, three-period crossover, 8-hour hyperinsulinemic-euglycemic clamp study will compare the pharmacokinetic and pharmacodynamic profiles of THDB0206 after single subcutaneous administration at different injection sites in healthy Chinese adults.
Interventions
DRUGTHDB0206 injection-Upper arm
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm.
DRUGTHDB0206 Injection-Abdomen
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen.
DRUGTHDB0206 Injection-Thigh
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh.
Sponsors
Tonghua Dongbao Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged ≥18 and ≤40 years at screening. 2. Body mass index (BMI) ≥18 kg/m² and \<25 kg/m² at screening; body weight ≥50 kg for males and ≥45 kg for females at screening. 3. At screening, 75 g oral glucose tolerance test (OGTT): fasting venous plasma glucose \<6.1 mmol/L and 2-hour post-load venous plasma glucose \<7.8 mmol/L. 4. Glycated hemoglobin (HbA1c) ≤6.1% at screening.
Exclusion criteria
1. Known or suspected hypersensitivity to the investigational product or related products, or a history of severe allergies to drugs or foods. 2. Insulin release test at screening considered abnormal with clinical significance in the investigator's judgment. 3. Increased risk of thromboembolism, such as known coagulation disorders, (family) history of thrombosis, or relevant arrhythmias (e.g., paroxysmal atrial fibrillation). 4. In the investigator's judgment, a history of alcohol dependence or drug/chemical substance abuse; or positive results on drug screening/breath alcohol testing at screening; or alcohol consumption exceeding 21 units per week (male subjects) or 14 units per week (female subjects). 5. Subjects who smoked on average more than 5 cigarettes per day within 1 year prior to screening and are unwilling to abstain from smoking during the study. 6. Donation of blood or plasma within the past month, or donation of more than 300 mL of blood within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCLisp(0-inf) | From 0 to 8 hours | Area under the insulin lispro plasma concentration-time curve from zero to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCLisp | From 0 to 8 hours | Area under the insulin lispro plasma concentration-time curve |
| tmax(Lisp) | From 0 to 8 hours | Time to reach the maximum insulin lispro plasma concentration |
| t1/2 | From 0 to 8 hours | Terminal half-life |
| CL/F | From 0 to 8 hours | CL/F |
| Vz/F | From 0 to 8 hours | Apparent volume of distribution |
| AUCGIR | From 0 to 8 hours | Area under the glucose infusion rate-time curve |
| GIRtot | From 0 to 8 hours | Total glucose infusion during clamping |
| GIRmax | From 0 to 8 hours | Maximum glucose infusion rate |
| Cmax (Lisp) | From 0 to 8 hours | The maximum plasma concentration of insulin lispro observed |
| Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) | — |
| Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) | — |
| Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) | — |
| Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) | — |
| Number of participants with hypoglycemia events in each treatment arm | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) | — |
| Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration, and others) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) | — |
| Number of participants with AE and SAE | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) | — |
| tGIRmax | From 0 to 8 hours | Time to reach the maximum glucose infusion rate |
Countries
China
Outcome results
None listed