Pain AcutePhase 1NCT07335913
Phase 1 Study of SBS-147 in Healthy Adults
A Phase 1 study testing SBS-147 in people with Pain Acute and Pain, run by Sparian Biosciences, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Acute, Pain
- What is being tested?
- SBS-147
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 participant as healthy
- 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, jeopardize complete participation in the study, or compromise interpretation of study data
- 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 < 90 or > 140 mmHg or diastolic blood pressure < 40 or > 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 hypokalaemia, hypercalcaemia, or hypomagnesaemia
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AltaSciences, Inc
Cypress, California, 90630
David Nguyen, MD, 913 696-1601, regulatory@altasceinces.com
About this study
Official title: 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 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
- Conditions
- Pain Acute, Pain
- Being tested
- SBS-147, Placebo
- Keywords
- Arylepoxamide, AEAr Agonist, 6TM, Tolerability, Safety, SBS-147, SBS147
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBS-147Drug
Experimental therapeutic
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Single dose of SBS-147 or a placebo given during trial Receives: Drug: SBS-147; Drug: Placebo |
| Multiple Ascending Dose | Experimental | SBS-147 or placebo given repeatedly over several days during the trial Receives: Drug: SBS-147; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 days
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.
Measured: 14 days
Secondary outcomes (2)
Relative plasma exposure of SBS-1000 compared with SBS-147 (SAD)
Geometric mean ratios (SBS-1000 / SBS-147) for Cmax and AUC
Measured: 0-12 hours, 0-24 hours, and extrapolated to infinity after dosing
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.
Measured: Day 1 (single-dose PK) and Day 7 at steady state over the dosing interval (τ)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start8 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sparian Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Altasciences Company Inc.
- Responsible party
- Sponsor
- Investigators
- Jeff Reich, MD, Study director, Sparian Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335913
- Sponsor's protocol ID
- SBS147-AP-107
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07335913
- Acronym / sponsor ID
- SBS147-AP-107
- Conditions
- Pain Acute, Pain
- Keywords
- Arylepoxamide, AEAr Agonist, 6TM, Tolerability, Safety, SBS-147, SBS147
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sparian Biosciences, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Altasciences Company Inc.
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: SBS-147, Drug: PlaceboSingle dose of SBS-147 or a placebo given during trial |
| Multiple Ascending Dose | Experimental | Drug: SBS-147, Drug: PlaceboSBS-147 or placebo given repeatedly over several days during the trial |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBS-147Experimental therapeutic | Drug | Multiple Ascending Dose, Single Ascending Dose |
| PlaceboPlacebo comparator | Drug | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 8 days
To assess the number of treatment emergent adverse events experienced in participants after a single dose of SBS-147
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 at ascending doses
Time frame: 14 days
Assess the number of treatment emergent adverse events experienced by participants of SBS-147 after multiple dose oral administration in healthy adults.
2 secondary outcomes
Relative plasma exposure of SBS-1000 compared with SBS-147 (SAD)
Time frame: 0-12 hours, 0-24 hours, and extrapolated to infinity after dosing
Plasma pharmacokinetics of SBS-1000 and SBS-147 following multiple ascending doses
Time frame: Day 1 (single-dose PK) and Day 7 at steady state over the dosing interval (τ)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeff Reich, MD study director
Sparian Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SBS-147 in people with Pain Acute and Pain, run by Sparian Biosciences, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oscar McClyde (913-696-1601, omcclyde@altasciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.