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| Name | Class |
|---|---|
| Linear Clinical Research | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, single ascending-dose study to investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5 μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.
Forty eight eligible participants will be enrolled into the 6 dose cohorts. For each cohort, a sentinel group of 2 subjects (1 receiving SHR0410 and 1 receiving placebo) will be dosed first (1:1 ratio). If no drug related adverse events occur in the sentinel participants, the remaining 6 subjects in a cohort will be dosed on the next day or later in a 5:1 ratio (5 subjects receiving SHR0410 and 1 subject receiving placebo). SHR0410 will be diluted in saline and administered as a 15 min constant dose IV infusion at a rate of 20 ml/hr on Day 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 μg/kg SHR0410 | Experimental | 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 0.5μg/kg SHR0410 (n=6) or placebo (n=2) |
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| 1 μg/kg SHR0410 | Experimental | 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 1μg/kg SHR0410 (n=6) or placebo (n=2) |
|
| 2 μg/kg SHR0410 | Experimental | 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 2μg/kg SHR0410 (n=6) or placebo (n=2) |
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| 5 μg/kg SHR0410 | Experimental | 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 5μg/kg SHR0410 (n=6) or placebo (n=2) |
|
| 10 μg/kg SHR0410 | Experimental | 8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10μg/kg SHR0410 (n=6) or placebo (n=2) |
|
| 20 μg/kg SHR0410 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5μg/kg SHR0410 | Drug | a single dose of 0.5μg/kg SHR0410 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events in terms of changes in Hematology | Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count | Up to Day 8 |
| Incidence of Adverse events in terms of changes in Urinalysis | Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites | Up to Day 8 |
| Incidence of Adverse events in terms of changes in Biochemistry (fasting) | Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol | Up to Day 8 |
| Incidence of Adverse events in terms of changes in Physical examinations | Review of body weight and height; general appearance; head; eyes; ears/nose/throat; neck; lymph nodes; neurological and musculoskeletal systems; heart; lungs; abdomen; skin; and extremities | Up to Day 8 |
| Incidence of Adverse events in terms of changes in Vital signs | Oral temperature, respiratory rate, blood pressure, and pulse rate | Up to Day 8 |
| Incidence of Adverse events in terms of changes in 12-lead ECGs | The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Plasma SHR0410 Area Under the Concentration-time Curve (AUC) | Up to 24 hours post dose |
| Time to the peak plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research Limited | Nedlands | Australia |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Experimental |
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10μg/kg SHR0410 (n=6) or placebo (n=2) |
|
| 1μg/kg SHR0410 |
| Drug |
a single dose of 2μg/kg SHR0410 |
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| 2μg/kg SHR0410 | Drug | a single dose of 2μg/kg SHR0410 |
|
| 5μg/kg SHR0410 | Drug | a single dose of 5μg/kg SHR0410 |
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| 10μg/kg SHR0410 | Drug | a single dose of 10μg/kg SHR0410 |
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| 20μg/kg SHR0410 | Drug | a single dose of 20μg/kg SHR0410 |
|
| Up to Day 8 |
Time to Maximum Plasma SHR0410 Concentration
| Up to 24 hours post dose |
| Peak Plasma Concentration (Cmax) | Peak Plasma SHR0410 Concentration | Up to 24 hours post dose |
| Half-time (T1/2) | Half-time of SHR0410 | Up to 24 hours post dose |
| Urine output rate | Changes in urine output rate from baseline | Up to 48 hours post dose |
| Serum prolactin release rate | Changes in serum prolactin release rate from baseline | Up to 48 hours post dose |