PainPhase 1NCT05721287
A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults
A Phase 1 study testing SBS-1000 in people with Pain and Acute Pain, run by Sparian Biosciences, Inc at 1 site in United States.
Trial summary
This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute Pain
- What is being tested?
- SBS-1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 30 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 59 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 59 years, inclusive, at Screening
- Body mass index (BMI) within 18.0 kg/m^2 to 33.0 kg/m^2, inclusively
- Minimum body weight of at least 50.0 kg at Screening
- Willingness to comply with all study procedures
- If female, agrees to use an acceptable contraceptive method.
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- If male, agrees to use an acceptable contraceptive method.
- Healthy as determined by no clinically significant findings at screening and clinic admission.
- Non- or ex-smoker
Who cannot join
- Has a current medical condition that would affect sensitivity to cold or pain
- Personal or family history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic, or other clinically significant disease that may interfere with the study
- Any clinically significant illness in the 28 days prior to the first study drug administration
- Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy
- Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Any clinically significant laboratory results at screening or prior to the first drug administration
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- intake of an investigational product within 28 days prior to study drug administration.
- Positive test for alcohol and/or drugs of abuse
- Positive for HIV or hepatitis
- Donation of plasma 7 days prior to study drug administration and/or donation of blood within 56 days prior to study drug administration.
- Significant ECG abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of SBS-1000 Administered by Intravenous Infusion to Healthy Adult Subjects
This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.
Read the detailed description
This study will be a single-center (clinical research unit), double-blind, placebo-controlled, randomized, adaptive, single-ascending dose study receiving either Investigational Product (IP [SBS-1000]) or placebo IV infusion. Up to 56 subjects will be randomized.
A total of 6 ascending dose cohorts will be used to assess the MTD of SBS-1000. Each cohort will be comprised of up to 8 subjects randomized 6:2 (IP:placebo). A sentinel group of 2 subjects randomized 1:1 (IP:placebo) will be used for each cohort with the sentinel group being dosed at least 48 hours prior to dosing the remaining subjects of the cohort, and contingent on the results of ongoing safety evaluation.
Blood samples will be collected over 72 hours postdose and urine samples over 48 hours postdose for pharmacokinetic (PK) assessments in all cohorts. Pharmacodynamic assessments will be performed throughout the study in cohorts 1 through 6. The sampling parameters may be adjusted based on the interim safety review.
Once the maximum tolerated dose (MTD) is established, dosing with the MTD or a lower dose, as determined by an interim safety review, an additional cohort (7) will occur to investigate the cardiodynamic effects of SBS-1000 using Holter monitoring. Cohort 7 will be comprised of 8 subjects randomized 6:2 (IP:placebo). No sentinel dosing administration will occur in this cohort.
- Conditions
- Pain, Acute Pain
- Being tested
- SBS-1000, Placebo
- Keywords
- Arylepoxamide, Safety, Tolerability, SBS-1000, SBS1000, 6TM, AEAr Agonist
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBS-1000Drug
Also called arylepoxamide agonist
SBS-1000 administered as a single continuous IV infusion over 60 minutes
PlaceboDrug
Also called sodium chloride
Normal saline (0.9% sodium chloride [NaCl]) administered as a single dose IV infusion over 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| SBS-1000 | Active comparator | Investigational Product Receives: Drug: SBS-1000 |
| Placebo | Placebo comparator | Normal saline (0.9% sodium chloride [NaCl]) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events (AEs)
Adverse events as assessed by electrocardiogram, vital signs, end-tidal carbon dioxide, oxygen saturation, physical examination, clinical laboratory tests, OAAS, C-SSRS, slit-lamp examination, gastrointestinal/esophageal assessment and concomitant medications
Measured: From start of infusion to 4 (±2) days after the last blood draw in the study
Secondary outcomes (1)
Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000
Assessment of systemic pharmacokinetics (PK) and urinary excretion of SBS-1000 by evaluation of AUC, Cmax, tmax, Ke t 1/2, Cl, V and Urine PK
Measured: From start of infusion to 72 hours post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start30 Jan 2023
- Primary completion15 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sparian Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Reich, MD, Study director, Sparian Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721287
- Sponsor's protocol ID
- SBS1000-AP-101
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of SBS-1000 Administered by Intravenous Infusion to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05721287
- Acronym / sponsor ID
- SBS1000-AP-101
- Conditions
- Pain, Acute Pain
- Keywords
- Arylepoxamide, Safety, Tolerability, SBS-1000, SBS1000, 6TM, AEAr Agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sparian Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 10 Feb 2023 (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 will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.
Detailed description
This study will be a single-center (clinical research unit), double-blind, placebo-controlled, randomized, adaptive, single-ascending dose study receiving either Investigational Product (IP [SBS-1000]) or placebo IV infusion. Up to 56 subjects will be randomized.
A total of 6 ascending dose cohorts will be used to assess the MTD of SBS-1000. Each cohort will be comprised of up to 8 subjects randomized 6:2 (IP:placebo). A sentinel group of 2 subjects randomized 1:1 (IP:placebo) will be used for each cohort with the sentinel group being dosed at least 48 hours prior to dosing the remaining subjects of the cohort, and contingent on the results of ongoing safety evaluation.
Blood samples will be collected over 72 hours postdose and urine samples over 48 hours postdose for pharmacokinetic (PK) assessments in all cohorts. Pharmacodynamic assessments will be performed throughout the study in cohorts 1 through 6. The sampling parameters may be adjusted based on the interim safety review.
Once the maximum tolerated dose (MTD) is established, dosing with the MTD or a lower dose, as determined by an interim safety review, an additional cohort (7) will occur to investigate the cardiodynamic effects of SBS-1000 using Holter monitoring. Cohort 7 will be comprised of 8 subjects randomized 6:2 (IP:placebo). No sentinel dosing administration will occur in this cohort.
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 |
|---|---|---|
| SBS-1000 | Active comparator | Drug: SBS-1000Investigational Product |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline (0.9% sodium chloride [NaCl]) |
Who may qualify
- Ages
- 18 to 59 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 59 years, inclusive, at Screening
- Body mass index (BMI) within 18.0 kg/m^2 to 33.0 kg/m^2, inclusively
- Minimum body weight of at least 50.0 kg at Screening
- Willingness to comply with all study procedures
Key exclusion criteria (11 listed)
- Has a current medical condition that would affect sensitivity to cold or pain
- Personal or family history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic, or other clinically significant disease that may interfere with the study
- Any clinically significant illness in the 28 days prior to the first study drug administration
- Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy
- Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs)
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-1000Also: arylepoxamide agonistSBS-1000 administered as a single continuous IV infusion over 60 minutes | Drug | SBS-1000 |
| PlaceboAlso: sodium chlorideNormal saline (0.9% sodium chloride [NaCl]) administered as a single dose IV infusion over 60 minutes | Drug | Placebo |
Primary outcome
Number of subjects with adverse events (AEs)
Time frame: From start of infusion to 4 (±2) days after the last blood draw in the study
Adverse events as assessed by electrocardiogram, vital signs, end-tidal carbon dioxide, oxygen saturation, physical examination, clinical laboratory tests, OAAS, C-SSRS, slit-lamp examination, gastrointestinal/esophageal assessment and concomitant medications
1 secondary outcome
Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000
Time frame: From start of infusion to 72 hours post-infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- 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. This study is not recruiting at the moment.
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-1000 in people with Pain and Acute 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 11 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: finished, as of the sponsor's last update on 26 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (AEs) (time frame: From start of infusion to 4 (±2) days after the last blood draw in the study). 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 26 Nov 2025.