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This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.
This study will be a single-center (clinical research unit), double-blind, placebo-controlled, randomized, adaptive, single-ascending dose study receiving either Investigational Product (IP [SBS-1000]) or placebo IV infusion. Up to 56 subjects will be randomized.
A total of 6 ascending dose cohorts will be used to assess the MTD of SBS-1000. Each cohort will be comprised of up to 8 subjects randomized 6:2 (IP:placebo). A sentinel group of 2 subjects randomized 1:1 (IP:placebo) will be used for each cohort with the sentinel group being dosed at least 48 hours prior to dosing the remaining subjects of the cohort, and contingent on the results of ongoing safety evaluation.
Blood samples will be collected over 72 hours postdose and urine samples over 48 hours postdose for pharmacokinetic (PK) assessments in all cohorts. Pharmacodynamic assessments will be performed throughout the study in cohorts 1 through 6. The sampling parameters may be adjusted based on the interim safety review.
Once the maximum tolerated dose (MTD) is established, dosing with the MTD or a lower dose, as determined by an interim safety review, an additional cohort (7) will occur to investigate the cardiodynamic effects of SBS-1000 using Holter monitoring. Cohort 7 will be comprised of 8 subjects randomized 6:2 (IP:placebo). No sentinel dosing administration will occur in this cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBS-1000 | Active Comparator | Investigational Product |
|
| Placebo | Placebo Comparator | Normal saline (0.9% sodium chloride [NaCl]) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBS-1000 | Drug | SBS-1000 administered as a single continuous IV infusion over 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs) | Adverse events as assessed by electrocardiogram, vital signs, end-tidal carbon dioxide, oxygen saturation, physical examination, clinical laboratory tests, OAAS, C-SSRS, slit-lamp examination, gastrointestinal/esophageal assessment and concomitant medications | From start of infusion to 4 (±2) days after the last blood draw in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000 | Assessment of systemic pharmacokinetics (PK) and urinary excretion of SBS-1000 by evaluation of AUC, Cmax, tmax, Ke t 1/2, Cl, V and Urine PK | From start of infusion to 72 hours post-infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Reich, MD | Sparian Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | Normal saline (0.9% sodium chloride [NaCl]) administered as a single dose IV infusion over 60 minutes |
|
|
| D017670 |
| Sodium Compounds |