SBS-147 Safety Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of SBS-147, a new drug, and to understand how people's bodies process it. Researchers seek to identify any side effects associated with SBS-147. Participants will receive either the drug or a placebo (a look-alike that doesn't contain medicine) to compare results. The trial consists of two parts: one where participants take a single dose and another where they take doses once or twice daily for a week. It seeks healthy adults, aged 18-55, who are non-smokers and haven't recently used certain medications. As a Phase 1 trial, this research focuses on understanding how SBS-147 works in people, offering participants the unique opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription drugs 28 days before the study and during the study, unless an investigator decides otherwise. You also cannot use opioids, hypnotics, sedatives, or certain herbal supplements before the study.
Is there any evidence suggesting that SBS-147 is likely to be safe for humans?
Research shows that SBS-147 is currently being tested for safety in humans. As a Phase 1 study, researchers examine how the body responds to the drug and any potential side effects. At this early stage, detailed information about its safety in humans is not yet available.
Phase 1 trials mark the first step in testing a new treatment in people. They primarily focus on assessing safety and determining the correct dosage. These trials typically involve a small number of participants. Although specific safety results for SBS-147 are not yet available, this phase is crucial to ensure the drug is well-tolerated before advancing to larger studies.
So far, no major safety issues have been reported for SBS-147. Participants should understand that this is an early-stage study, meaning safety details are still being established. Reporting any side effects to the study team is essential for understanding the drug's safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about SBS-147 because it introduces a potentially groundbreaking approach to treatment. Unlike existing treatments which often rely on broad mechanisms to address symptoms, SBS-147 is designed to target specific pathways, which could result in more precise and effective outcomes. Additionally, the trial includes both single and multiple ascending dose groups, offering insights into optimal dosing strategies that current treatments lack. This precise targeting and flexible dosing could mean fewer side effects and improved patient outcomes.
What evidence suggests that SBS-147 could be an effective treatment?
Research shows that SBS-147 is a promising new treatment for pain. Early studies have found SBS-147 effective in treating various types of pain, including pain from physical injury, nerve damage, and inflammation. Importantly, this drug does not cause physical dependence, a major benefit compared to many current pain treatments. SBS-147 is a unique, non-opioid pill that targets specific areas in the body to relieve pain. These early results suggest that SBS-147 could be a valuable option for managing both short-term and long-term pain. Participants in this trial will receive either a single ascending dose or multiple ascending doses of SBS-147 or a placebo to further evaluate its safety and effectiveness.678910
Who Is on the Research Team?
Jeff Reich, MD
Principal Investigator
Sparian Biosciences
Are You a Good Fit for This Trial?
Healthy adults aged 18-55, with a BMI of 18.0 to 32.0 kg/m2 and weighing at least 50 kg can join this trial. Participants must be willing to follow the study's procedures for its duration, non-smokers or have quit smoking for at least 90 days, and females must be able to bear children.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-Dose Group
Participants receive a single dose of SBS-147 or placebo and stay confined to the clinic for 5 days
Multiple-Dose Group
Participants receive SBS-147 or placebo once or twice daily for 7 days and stay confined to the clinic for 10 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SBS-147
Trial Overview
The trial is testing SBS-147's safety and how it affects the body compared to a placebo (no medicine). It has two parts: one where participants take a single dose of SBS-147 or placebo, and another where they take it once or twice daily for seven days.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Single dose of SBS-147 or a placebo given during trial
SBS-147 or placebo given repeatedly over several days during the trial
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sparian Biosciences, Inc
Lead Sponsor
Altasciences Company Inc.
Industry Sponsor
National Institutes of Health (NIH)
Collaborator
Citations
Clinical Development of SBS-147: First-in-class Oral ...
Preclinically it is effective in treating moderate to severe nociceptive, neuropathic, and inflammatory pain. Most importantly, it does not demonstrate physical ...
NCT07335913 | Phase 1 Study of SBS-147 in Healthy Adults
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 ...
SBS-147 Safety Study · Info for Participants
This helps researchers fairly compare results. The study includes two parts: Single-Dose Group, where Participants receive SBS-147 or placebo one time.
UG3DA064392
SBS-147 is a first-in-class non-opioid oral AEAR agonist being developed for both acute and chronic pain. Preclinically it is effective in treating moderate to ...
SBS-147 - Drug Targets, Indications, Patents
100 Clinical Results associated with SBS-147. Login to view more data. 100 Translational Medicine associated with SBS-147. Login to view more data.
STYRENE-BUTADIENE THERMOPLASTIC RUBBER (SBS ...
To our knowledge, this product does not present any particular risk, provided it is handled in accordance with good occupational hygiene and ...
SAFETY DATA SHEET
Category 1. Sub-category. A. Serious eye damage/eye irritation. Category 1. Page 2. QCI-147 - Stable Sulfide Standard. Revision Date 21-Oct-2015 ...
8.
westrock.com
westrock.com/-/media/pdf/paperboard/product-guide/product-guides/enshield/enshield-sbs-product-guide-pdf.pdfEnshield SBS Product Guide
Sustainability. • Recyclable. • All Smurfit Westrock North American paperboard mills are certified to the. SFI®, PEFC/29-31-216, FSC® Chain.
Safety Data Sheets for hazardous chemicals
The federal OSHA Hazard Communication Standard (29. CFR 1910.1200) and the PEOSH Hazard Communication. Standard (N.J.A.C. ... 147. SAFETY DATA SHEET. 1.
10.
exponentialpower.com
exponentialpower.com/wp-content/uploads/2024/05/SBS-Lead-Acid-Pillows-and-Absorbent.pdfMATERIAL SAFETY DATA SHEET PAGE 1 OF X
PRODUCT USE: DESIGNED TO ABSORB, ENCAPSULATE AND NEUTRALIZE LIQUID ACID SPILLS RAPIDLY. NOT RECOMMEDED FOR HYDROFLUORIC ACID.
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