Acute Pain, Pain
Conditions
Keywords
Arylepoxamide, Safety, Tolerability, SBS-1000, SBS1000, 6TM, AEAr Agonist
Brief summary
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.
Interventions
DRUGSBS-1000
SBS-1000 administered as a single continuous IV infusion over 60 minutes
DRUGPlacebo
Normal saline (0.9% sodium chloride \[NaCl\]) administered as a single dose IV infusion over 60 minutes
Sponsors
Sparian Biosciences, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent form (ICF) 2. Healthy adult male or female, aged 18 to 59 years, inclusive, at Screening 3. Body mass index (BMI) within 18.0 kg/m\^2 to 33.0 kg/m\^2, inclusively 4. Minimum body weight of at least 50.0 kg at Screening 5. Willingness to comply with all study procedures 6. If female, agrees to use an acceptable contraceptive method. 7. If male, agrees to use an acceptable contraceptive method. 8. Healthy as determined by no clinically significant findings at screening and clinic admission. 9. Non- or ex-smoker
Exclusion criteria
1. Has a current medical condition that would affect sensitivity to cold or pain 2. 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 3. Any clinically significant illness in the 28 days prior to the first study drug administration 4. 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 5. Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs) 6. Any clinically significant laboratory results at screening or prior to the first drug administration 7. intake of an investigational product within 28 days prior to study drug administration. 8. Positive test for alcohol and/or drugs of abuse 9. Positive for HIV or hepatitis 10. Donation of plasma 7 days prior to study drug administration and/or donation of blood within 56 days prior to study drug administration. 11. Significant ECG abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events (AEs) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000 | From start of infusion to 72 hours post-infusion | 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 |
Countries
United States
Outcome results
None listed