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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Altasciences Company Inc. | INDUSTRY |
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This study is part of the HEAL Initiative supported by the NIH.
The purpose of this study is to learn how safe the study drug, SBS-147, is and how people's bodies respond to and process it. Researchers will also look for any side effects that may occur when taking SBS-147.
Some participants will receive SBS-147, and others will receive a placebo, which looks the same but does not contain any medicine. This helps researchers fairly compare results.
The study includes two parts:
Single-Dose Group, where Participants receive SBS-147 or placebo one time.
Multiple-Dose Group, where Participants receive SBS-147 or placebo once or twice daily for 7 days.
The goal of this clinical trial is to learn about the safety of SBS-147. The main questions it aims to answer are:
What medical problems do participants have when taking SBS-147? Researchers will compare SBS-147 to a placebo (a look-alike substance that contains no drug) to see if SBS-147 works to treat acute pain.
Participants in the single ascending dose portion will:
Take SBS-147 or a placebo one time during the study Stay confined to the clinic for a period of 5 days and undergo tests, blood draws, and questionnaires.
Complete an end of study visit on Day 8
Participants in the multiple ascending dose portion will:
Take SBS-147 or a placebo one time per day or twice a day for 7 days Stay confined to the clinic for a period of 10 days and undergo tests, blood draws, and questionnaires.
Complete an end of study visit on Day 14
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose | Experimental | Single dose of SBS-147 or a placebo given during trial |
|
| Multiple Ascending Dose | Experimental | SBS-147 or placebo given repeatedly over several days during the trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBS-147 | Drug | Experimental therapeutic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | To assess the number of treatment emergent adverse events experienced in participants after a single dose of SBS-147 | 8 days |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 at ascending doses | Assess the number of treatment emergent adverse events experienced by participants of SBS-147 after multiple dose oral administration in healthy adults. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relative plasma exposure of SBS-1000 compared with SBS-147 (SAD) | Geometric mean ratios (SBS-1000 / SBS-147) for Cmax and AUC | 0-12 hours, 0-24 hours, and extrapolated to infinity after dosing |
| Plasma pharmacokinetics of SBS-1000 and SBS-147 following multiple ascending doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oscar McClyde | Contact | 913-696-1601 | omcclyde@altasciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeff Reich, MD | Sparian Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AltaSciences, Inc | Recruiting | Cypress | California | 90630 | United States |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Placebo comparator |
|
Plasma concentrations of SBS-1000 and SBS-147 will be analyzed using noncompartmental methods to characterize single-dose and steady-state pharmacokinetics. |
| Day 1 (single-dose PK) and Day 7 at steady state over the dosing interval (τ) |