Phase 1 testing 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
This study will test if SBS-147 is safe and how healthy adults' bodies handle single or repeated doses compared with a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Sparian Biosciences, Inc Industry-sponsored |
| Locations | 1 site (Cypress, California) |
| Trial ID | NCT07335913 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 1 trial in healthy adults aims to characterize the safety, tolerability, and pharmacokinetics of SBS-147, an AEAr agonist candidate for acute pain. The study has two parts: a single-ascending-dose cohort with a one-time dose and approximately 5 days of in-clinic confinement, and a multiple-ascending-dose cohort with once- or twice-daily dosing for 7 days and approximately 10 days of confinement. Participants will be randomized to receive SBS-147 or matching placebo, undergo blood draws, safety monitoring, and questionnaires, and complete follow-up visits through Day 8 or Day 14. The study is sponsored by Sparian Biosciences with NIH support and conducted at AltaSciences in Cypress, California.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18–55 with BMI 18–32 kg/m2 who are non- or ex-smokers, not pregnant or breastfeeding, and willing to stay in the clinic for the required confinement periods.
Not a fit: People with active medical conditions, pregnant or breastfeeding women, current smokers, or patients seeking treatment for ongoing pain are unlikely to receive direct clinical benefit from participation.
Why it matters
Potential benefit: If successful, SBS-147 could lead to a new non-opioid option for treating acute pain with a different receptor mechanism.
How similar studies have performed: This is a first-in-human Phase 1 trial so human data are limited, although related preclinical studies of AEAr agonists have shown promise for pain reduction.
Eligibility criteria
Show full inclusion / exclusion criteria
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 protocol procedures and requirements Exclusion Criteria: 1. Female who is lactating at Screening 2. Female who is pregnant 3. History of significant hypersensitivity reactions (like angioedema) to any drugs 4. Presence or history of significant surgery that may affect drug bioavailability 5. History of significant CV, pulmonary, hematologic, neurologic, psychiatric, endocrine, infectious, or immunologic disease 6. 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 7. Showing suicidal tendency as per the C-SSRS administered at screening and clinic admission 8. Any clinically significant illness in the 28 days prior to the first study drug administration 9. 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 participant as healthy 10. Use of opioids, hypnotics, and/or sedatives in the last 30 days prior to screening 11. Routine or chronic use of acetaminophen or nonsteroidal anti-inflammatory drugs for more than 7 of the 20 days during the screening period. 12. Use of St. John's Wort in the 28 days prior to Screening 13. Use of any herbal supplements (including Kratom) the 14 days prior to Screening 14. Intake of an Investigational Product (IP) in the 30 days prior to Screening 15. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration 16. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus Ab tests 17. 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, jeopardize complete participation in the study, or compromise interpretation of study data 18. Donation of plasma in the 7 days prior to Screening 19. 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 20. Inclusion in a previous cohort for this clinical study 21. Supine pulse rate less than 45 beats per minute (bpm) or more than 100 bpm at the screening visit 22. Supine systolic blood pressure \< 90 or \> 140 mmHg or diastolic blood pressure \< 40 or \> 90 mmHg at the Screening visit 23. Oxygen saturation (SpO2) below 95% at the Screening visit 24. 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 25. 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 hypokalaemia, hypercalcaemia, or hypomagnesaemia 26. Family history of long QT syndrome or Brugada syndrome 27. History of fainting 28. Family history of sudden cardiac death or significant heart disease 29. Known presence or history of gastroesophageal reflux or hiatal hernia
Where this trial is running
Cypress, California
- AltaSciences, Inc — Cypress, California, United States (Recruiting)
Study contacts
- Study coordinator: Oscar McClyde
- Email: omcclyde@altasciences.com
- Phone: 913-696-1601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.