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RecruitingNCT07335913Updated Mar 3, 2026

Phase 1 Study of SBS-147 in Healthy Adults

A Phase 1 interventional study of SBS-147 and Placebo in Pain Acute and Pain, sponsored by Sparian Biosciences, Inc. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Sparian Biosciences, Inc · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed 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 multiple ascending dose portion will:

Take SBS-147 or a placebo one time per day or twice a day for 7 days Stay confined to the clinic for a period of 10 days and undergo tests, blood draws, and questionnaires.

Complete an end of study visit on Day 14

02

Conditions studied

  • Pain Acute
  • Pain

Browse trials for

Keywords

  • Arylepoxamide
  • AEAr Agonist
  • 6TM
  • Tolerability
  • Safety
  • SBS-147
  • SBS147
03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's planned enrollment of 80 is below the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Sparian Biosciences, Inc is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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 protocol procedures and requirements

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Single Ascending Dose

    Single dose of SBS-147 or a placebo given during trial

    Drug: SBS-147 · Drug: Placebo

  • Experimental
    Multiple Ascending Dose

    SBS-147 or placebo given repeatedly over several days during the trial

    Drug: SBS-147 · Drug: Placebo

Interventions

  • DrugSBS-147

    Experimental therapeutic

  • DrugPlacebo

    Placebo comparator

06

What researchers measure

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    To assess the number of treatment emergent adverse events experienced in participants after a single dose of SBS-147

    Time frame: 8 days

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 at ascending doses

    Assess the number of treatment emergent adverse events experienced by participants of SBS-147 after multiple dose oral administration in healthy adults.

    Time frame: 14 days

Secondary outcomes

  1. Relative plasma exposure of SBS-1000 compared with SBS-147 (SAD)

    Geometric mean ratios (SBS-1000 / SBS-147) for Cmax and AUC

    Time frame: 0-12 hours, 0-24 hours, and extrapolated to infinity after dosing

  2. Plasma pharmacokinetics of SBS-1000 and SBS-147 following multiple ascending doses

    Plasma concentrations of SBS-1000 and SBS-147 will be analyzed using noncompartmental methods to characterize single-dose and steady-state pharmacokinetics.

    Time frame: Day 1 (single-dose PK) and Day 7 at steady state over the dosing interval (τ)

07

Study locations

1 of 1 sites recruiting
  • AltaSciences, Inc
    Cypress, California 90630, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07335913
Lead sponsor
Sparian Biosciences, Inc
Collaborators
National Institutes of Health (NIH), Altasciences Company Inc.
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Jan 8, 2026
Primary completion
Jan 31, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Mar 3, 2026

Study contacts

Oscar McClyde
Contact
omcclyde@altasciences.com
913-696-1601
Jeff Reich, MD
study director · Sparian Biosciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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