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
Sparian Biosciences, Inc
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.
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 multipl…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Provision of signed and dated informed consent form (ICF) 2. Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening 3. Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 inclusively 4. Minimum body weight of at least 50.0 kg at Screening 5. Stated willingness to comply with all study procedures and availability for the duration of the study 6. Females of childbearing potential 7. Healthy, as determined by protocol requirements 8. Non- or ex-smoker for at least 90 days prior to Screening 9. Participant is able and willing to comply with all study p…
Interventions
- DrugSBS-147
Experimental therapeutic
- DrugPlacebo
Placebo comparator
Location
- AltaSciences, IncCypress, California