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This study is a Phase I, randomized double-blind, placebo-controlled (within a dose group), single and multiple rising dose study of the intravenous administration of SB26 in healthy volunteers.
The study includes two Parts; Part 1 includes the FiH exposure and SRD and Part 2 is the MRD. Approximately 58 subjects will be enrolled in the study. New subjects will be recruited for each cohort in both Parts. The SRD Part will include 5 or more dose levels and the MRD Part will include 3 or more dose levels; additional dose level(s) may be added based on emerging safety and PK data from prior cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB26 for Part 1 | Experimental | SB26: various single doses, administered to various cohorts |
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| SB26 for Part 2 | Experimental | SB26: various multiple doses, administered to various cohorts |
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| Placebo for Part 1 | Placebo Comparator | SB26 matching placebo: various single doses, administered to various cohorts |
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| Placebo for Part 2 | Placebo Comparator | SB26 matching placebo: various multiple doses, administered to various cohorts |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB26 | Drug | SB26 administered intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAE | Experience at least 1 treatment-emergent adverse event | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Incidence of AE leading to discontinuation | Discontinue due to adverse event | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Abnormal hematology parameters | Meet the criteria for markedly abnormal hematology parameters. The following parameters will be analyzed: White blood cell, red blood cell, hemoglobin, platelet count. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Abnormal serum chemistry parameters | Meet the criteria for markedly abnormal serum chemistry parameters. The following parameters will be analyzed: Blood urea nitrogen, creatinine, total protein, albumin, alanine transaminase, aspartate transaminase. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Abnormal coagulation parameters | Meet the criteria for markedly abnormal coagulation parameters. The following parameters will be analyzed: Prothrombin time, activated partial thromboplastin time. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Abnormal urinalysis parameters | Meet the criteria for markedly abnormal urinalysis parameters. The following parameters will be analyzed: Protein, glucose, urobilinogen, bilirubin. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed serum concentration | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| tmax | Time to reach Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Han, M.D. | California Clinical Trials Medical Group, a division of PAREXEL International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International | Glendale | California | 91206 | United States |
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| Placebo | Drug | Placebo administered intravenously |
|
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| Abnormal blood pressure | Meet the criteria for markedly abnormal blood pressure. Systolic blood pressure (SBP), diastolic blood pressure (DBP) will be measured in a supine position after at least 5 minutes of rest. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Abnormal heart rate | Meet the criteria for markedly abnormal heart rate. It will be measured in a supine position after at least 5 minutes of rest. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Abnormal body temperature | Meet the criteria for markedly abnormal body temperature. It will be measured in a supine position after at least 5 minutes of rest. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Abnormal ECG | Meet the criteria for markedly abnormal 12-lead ECG parameter. QT interaval with Fridericia correction method (QTcF) value will be measured in a supine position after at least 10 minutes of rest. | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| AUClast | Area under the curve from the time of dosing to the time of the last measurable concentration | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Vd | Volume of distribution | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| CL | Total body clearance | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| t1/2 | Terminal half-life | Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| AUCinf | Area under the curve from the time of dosing extrapolated to infinity | Part 1: From Day 1 until Day 50 |
| Accumulation index | Predicted using terminal rate constant and dosing interval | Part 1: From Day 1 until Day 50 |
| AUCtau | Area under the serum concentration-time curve over the dosing interval | Part 2: From Day 1 until Day 71 |
| Accumulation ratio | Calculated using systemic exposure at first dosing and last dosing | Part 2: From Day 1 until Day 71 |
| Cmin | Minimum observed concentration | Part 2: From Day 1 until Day 71 |
| Incidence of ADA | Incidence of anti-drug antibody | From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Titer of ADAs | Titer of anti-drug antibodies to SB26 | From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |
| Incidence of NAb | Incidence of neutralizing antibody to SB26 | From Day 1 until Day 50; Part 2: From Day 1 until Day 71 |