NCT07335913

Phase 1 Study of SBS-147 in Healthy Adults

A PHASE 1, TWO-PART, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF ORALLY ADMINISTERED SBS-147 IN HEALTHY ADULTS

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sparian Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Pain Acute
• Pain

Interventions

Type	Name	Description
DRUG	SBS-147	Experimental therapeutic
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2026-01-08
• Primary completion: 2027-01-31
• Completion: 2027-02-28
• First posted: 2026-01-13
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study