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New treatment option for Pain Acute
Official title Phase 1 Study of SBS-147 in Healthy Adults
ClinicalTrials.gov ID: NCT07335913
What this study is testing
What is SBS-147?
SBS-147 is an investigational medicine, given as an once-daily, being studied as a potential treatment for pain acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Provision of signed and dated informed consent form (ICF)
- Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
- Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 inclusively
- Minimum body weight of at least 50.0 kg at Screening
- Stated willingness to comply with all study procedures and availability for the duration of the study
You likely can't join if
- Female who is lactating at Screening
- Female who is pregnant
- History of significant hypersensitivity reactions (like angioedema) to any drugs
- Presence or history of significant surgery that may affect drug bioavailability
- History of significant CV, pulmonary, hematologic, neurologic, psychiatric, endocrine, infectious, or immunologic disease
- Meet Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for lifetime or current substance use disorder for any psychoactive...
See the full eligibility criteria
- Provision of signed and dated informed consent form (ICF)
- Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
- Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 inclusively
- Minimum body weight of at least 50.0 kg at Screening
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Females of childbearing potential
- Healthy, as determined by protocol requirements
- Non- or ex-smoker for at least 90 days prior to Screening
- Participant is able and willing to comply with all study protocol procedures and requirements
- Female who is lactating at Screening
- Female who is pregnant
- History of significant hypersensitivity reactions (like angioedema) to any drugs
- Presence or history of significant surgery that may affect drug bioavailability
- History of significant CV, pulmonary, hematologic, neurologic, psychiatric, endocrine, infectious, or immunologic disease
- Meet Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for lifetime or current substance use disorder for any psychoactive substances other than nicotine or caffeine
- Showing suicidal tendency as per the C-SSRS administered at screening and clinic admission
- Any clinically significant illness in the 28 days prior to the first study drug administration
- Use of any prescription drugs in the 28 days or 5 half-lives, whichever is longer, prior to Screening and until the end of the study, that in the opinion of an Investigator would put into question the status of the...
- Use of opioids, hypnotics, and/or sedatives in the last 30 days prior to screening
- Routine or chronic use of acetaminophen or nonsteroidal anti-inflammatory drugs for more than 7 of the 20 days during the screening period.
- Use of St. John's Wort in the 28 days prior to Screening
- Use of any herbal supplements (including Kratom) the 14 days prior to Screening
- Intake of an Investigational Product (IP) in the 30 days prior to Screening
- Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus Ab tests
- Any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of an Investigator and based on clinical judgment, increase the participant's risk of participation...
- Donation of plasma in the 7 days prior to Screening
- Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to Screening
- Inclusion in a previous cohort for this clinical study
- Supine pulse rate less than 45 beats per minute (bpm) or more than 100 bpm at the screening visit
- Supine systolic blood pressure \ 140 mmHg or diastolic blood pressure \ 90 mmHg at the Screening visit
- Oxygen saturation (SpO2) below 95% at the Screening visit
- Presence of out-of-range cardiac interval on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator
- History of risk factors for Torsades de Pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including...
- Family history of long QT syndrome or Brugada syndrome
- History of fainting
- Family history of sudden cardiac death or significant heart disease
- Known presence or history of gastroesophageal reflux or hiatal hernia
The study team makes the final eligibility decision.
Where it's taking place
- Cypress, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cypress, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.