What is SBS-147 studying for acute pain?

SBS-147 is being studied to understand its safety, how the body processes it, and any side effects when taken by healthy adults. This trial compares SBS-147 to a placebo to fairly evaluate its effects. The study is supported by Sparian Biosciences, Inc as part of the HEAL Initiative.

Who may be eligible for this acute pain clinical trial?

Adults aged 18 to 55 who are healthy and willing to follow study procedures may be eligible. Both males and females can join, but females cannot be pregnant or breastfeeding. Participants should not have significant medical conditions or recent use of certain drugs. Please review eligibility criteria for more details.

Is there any cost to participate in this acute pain clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 18Years - 55Years

All Genders

Healthy Volunteers

ID07335913

Phase 1 Study of the Safety and Body Processing of Oral SBS-147 Compared to Placebo in Healthy Adults Aged 18 to 55

Led by Sparian Biosciences, Inc · Updated on 2026-03-03

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and how the body processes the drug SBS-147 in healthy adults aged 18 to 55 years. This Phase 1 trial is part of the HEAL Initiative and aims to identify any side effects when taking SBS-147 compared to a placebo. The study includes participants who do not have major health issues and are willing to follow study procedures. Participants are divided into two groups one group receives a single dose of SBS-147 or placebo, and the other group receives SBS-147 or placebo once or twice daily for 7 days. Those in the single-dose group stay in the clinic for 5 days, while those in the multiple-dose group stay for 10 days. Both groups complete an end-of-study visit, either on Day 8 or Day 14 depending on the dosing schedule. During the study, participants will have tests, blood draws, and questionnaires to monitor their health and how their body handles the drug. Researchers will watch for treatment-related side effects using specific criteria over 8 or 14 days. The study also measures how much SBS-147 and related substances are in the blood over time. Participants must be available for the full duration of the study and comply with all study procedures.

CONDITIONS

Brief Title

Phase 1 Study of SBS-147 in Healthy Adults

Who Can Participate

Age: 18Years - 55Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent form
Healthy male or female aged 18 to 55 years at screening
Body mass index between 18.0 and 32.0 kg/m2 inclusive
Minimum body weight of at least 50.0 kg at screening
Willingness to comply with all study procedures and availability for the study duration
Females of childbearing potential included
Healthy based on protocol requirements
Non-smoker or ex-smoker for at least 90 days prior to screening
Able and willing to comply with all study protocol procedures and requirements

You will not qualify if you...

Female who is lactating at screening
Female who is pregnant
History of significant hypersensitivity reactions to any drugs
History or presence of significant surgery affecting drug bioavailability
History of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, infectious, or immunologic disease
Lifetime or current substance use disorder (other than nicotine or caffeine) per DSM-5
Suicidal tendency per C-SSRS at screening and clinic admission
Any clinically significant illness in the 28 days before first drug administration
Use of prescription drugs in the 28 days or 5 half-lives before screening that could affect health status
Use of opioids, hypnotics, or sedatives in the last 30 days prior to screening
Routine or chronic use of acetaminophen or NSAIDs for more than 7 of 20 days during screening
Use of St. John's Wort within 28 days prior to screening
Use of herbal supplements including Kratom within 14 days prior to screening
Intake of investigational products in the 30 days prior to screening
Positive tests for alcohol, drugs of abuse, HIV, hepatitis B or C at screening
Clinically significant lab abnormalities increasing risk or compromising study data
Plasma donation within 7 days prior to screening
Blood donation over 500 mL in the 56 days prior to screening
Inclusion in a previous cohort of this study
Supine pulse rate less than 45 bpm or more than 100 bpm at screening
Blood pressure outside 90-140 mmHg systolic or 40-90 mmHg diastolic at screening
Oxygen saturation below 95% at screening
Significant ECG abnormalities unless deemed non-significant by investigator
History or family history of long QT syndrome, Brugada syndrome, heart failure, myocardial infarction, angina, or sudden cardiac death
History of fainting
Known presence or history of gastroesophageal reflux or hiatal hernia

Research Team

Oscar McClyde

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Phase 1 Study of the Safety and Body Processing of Oral SBS-147 Compared to Placebo in Healthy Adults Aged 18 to 55

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria