A Phase 1 interventional study of SBS-147 and Placebo in Pain Acute and Pain, sponsored by Sparian Biosciences, Inc. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Sparian Biosciences, Inc · Phase 1, Interventional, and Treatment
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
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 80 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Sparian Biosciences, Inc is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of SBS-147 or a placebo given during trial
Drug: SBS-147 · Drug: Placebo
SBS-147 or placebo given repeatedly over several days during the trial
Drug: SBS-147 · Drug: Placebo
Experimental therapeutic
Placebo comparator
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
Time frame: 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.
Time frame: 14 days
Relative plasma exposure of SBS-1000 compared with SBS-147 (SAD)
Geometric mean ratios (SBS-1000 / SBS-147) for Cmax and AUC
Time frame: 0-12 hours, 0-24 hours, and extrapolated to infinity after dosing
Plasma pharmacokinetics of SBS-1000 and SBS-147 following multiple ascending doses
Plasma concentrations of SBS-1000 and SBS-147 will be analyzed using noncompartmental methods to characterize single-dose and steady-state pharmacokinetics.
Time frame: Day 1 (single-dose PK) and Day 7 at steady state over the dosing interval (τ)
Plan to share: No
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Sparian Biosciences, Inc