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Sponsor internal strategy change.
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This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1816 after single and multiple injection with different dose regimens in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1816 | Drug | SHR-1816 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse Events | Day-2 to Day29/Day50 | |
| Incidence of hypoglycemic events | Day1 to Day8/Day29 | |
| Incidence of reaction of the injection sites | Day1 to Day8/Day29 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of SHR-1816 - AUC0-t | AUC0-t, area under the concentration-time curve from time 0 to the time of last quantifiable concentration; | pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacokinetic (PK) profile of SHR-1816 - AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
1) Any clinically significant lab tests abnormal with one-time retest. 2) ALT and AST were higher than the upper limit of normal value. 3) Subject who has fatty liver disease diagnosed by ultrasound examination. 4) Subject who has abnormal thyroid function. 5) The 12-lead electrocardiogram (ECG) is abnormal and clinically significant, or shows QTcF>450 ms in male and 470 ms in female.
6) Positive infectious diseases screening tests: HBsAg, HCV-Ab, TP-Ig G, HIV-Ab 2. Having any of the following diseases or history:
3. Use of any other medicine or other non-drug operations:
4. Any of the following conditions exists:
5. Other conditions or laboratory abnormality that may affect trial evaluations associated with study participation reviewed by the investigators.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
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SHR-1816 injection compared with placebo
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| Drug |
Placebo |
|
AUC0-inf, area under the concentration-time curve from time 0 to infinity; |
| pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacokinetic (PK) profile of SHR-1816 - Cmax | Cmax, observed maximum concentration; | pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacokinetic (PK) profile of SHR-1816 - Tmax | Tmax, time of occurrence of Cmax; | pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacokinetic (PK) profile of SHR-1816 - Vz/F | Vz/F, apparent volume of distribution; | pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacokinetic (PK) profile of SHR-1816 - CL/F | CL/F, apparent clearance; | pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacokinetic (PK) profile of SHR-1816 - t1/2 | t1/2, terminal half-life; | pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacokinetic (PK) profile of SHR-1816 - MRTinf | MRTinf, mean residence time from time 0 to infinity. | pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose |
| Pharmacodynamic (PD) profile of doses of SHR-1816 - fasting blood glucose | Day-1 to Day15/Day29 |
| Pharmacodynamic (PD) profile of doses of SHR-1816 - insulin | Day-1 to Day15/Day29 |
| Pharmacodynamic (PD) profile of doses of SHR-1816 - C-peptide | Day-1 to Day15/Day29 |
| Pharmacodynamic (PD) profile of doses of SHR-1816 - glucagon | Day-1 to Day15/Day29 |
| Pharmacodynamic (PD) profile of doses of SHR-1816 - total GLP-1 | Day-1 to Day15/Day29 |
| Pharmacodynamic (PD) profile of doses of SHR-1816 - active GLP-1 | Day-1 to Day15/Day29 |
| Pharmacodynamic (PD) profile of doses of SHR-1816 - fructosamine | Day-1 to Day15/Day29 |
| PD profile of multiple doses of SHR-1816 - HbA1c | Day-1, Day29 |
| PD profile of multiple doses of SHR-1816 - 7-points glucose profile | Day-1 to Day15/Day29 |
| PD profile of multiple doses of SHR-1816 - weight | Day-1 to Day15/Day29 |
| Immunogenicity | Incidence of SHR-1816 antibody formation. | Day1 to Day29/Day50 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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