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The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 1. Drug: Placebo Subject will receive placebo at dose level 1. |
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| Group B | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 2. Drug: Placebo Subject will receive placebo at dose level 2. |
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| Group C | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 3. Drug: Placebo Subject will receive placebo at dose level 3. |
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| Group D | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 4. Drug: Placebo Subject will receive placebo at dose level 4. |
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| Group E | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 5. Drug: Placebo Subject will receive placebo at dose level 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4029 | Drug | HRS-4029 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | From ICF signing date to Day15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of HRS-4029 (Cmax) | 0 hour to 48 hour after administration | |
| Area under the serum concentration time curve (AUC) of HRS-4029 | 0 hour to 48 hour after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanyuan Huang | Contact | 0518-82342973 | yuanyuan.huang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Group F | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 6. Drug: Placebo Subject will receive placebo at dose level 6. |
|
| Placebo | Drug | Placebo |
|
| Time to maximum observed concentration (Tmax) of HRS-4029 | 0 hour to 48 hour after administration |
| Half-life (T1/2) of HRS-4029 | 0 hour to 48 hour after administration |
| Clearance (CL) of HRS-4029 | 0 hour to 48 hour after administration |
| Volume of distribution (Vz) of HRS-4029 | 0 hour to 48 hour after administration |
| Number of subjects who developed HRS-4029 antidrug antibodies (ADA) | Baseline to Day15 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |