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This is a randomized, double-blind, placebo-controlled, single-dose escalation trial was designed. There are 6 dose groups and 1 optional dose group: 0.5 mg, 2 mg, 8 mg, 25mg, 50 mg, 100 mg and 150 mg (optional). Eight healthy adult subjects or T2DM patients in each dose group (except for 0.5 mg dose group, only 4 subjects will be enrolled) are randomly assigned to subcutaneously injection of SHR-3167 or placebo according to 3:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3167 | Experimental |
| |
| SHR-3167 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3167 | Drug | SHR-3167, Single administration |
| |
| SHR-3167 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: Number of Adverse Events | A summary of adverse events, including Serious Adverse Events(SAEs) | Start of Treatment to end of study (approximately 92 days) |
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Inclusion Criteria:
Exclusion Criteria:
History of significant multiple and/or severe drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product
Presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, hematological, neurological, or psychiatric diseases or disorders.
History of severe cardiovascular and cerebrovascular disease, including heart failure (NYHA class II to IV), myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, 6 months before screening to before randomization;
T2DM patients:
a) Severe hypoglycemia, frequent hypoglycemia, ketoacidosis, or hypertonic coma from 6 months before screening to before randomization; b) Known proliferative diabetic retinopathy ordiabetic macular edema, or non-proliferative diabetic retinopathy requiring treatment during the trial;
Those who had a severe infection, severe trauma, or had undergone surgery in the 12 weeks prior to screening, or planned to undergo surgery during the trial
Participants who participated in a clinical trial of any other drug or medical device from 3 months prior to screening to before randomization or planned to participate during the study period
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Sun | Contact | +86 18036618718 | meng.sun@hengrui.com | |
| Zeming lin | Contact | +86 17721288239 | zeming.lin.zl5@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Drug |
SHR-3167 Placebo Single administration |
|