A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Pain; Acute Pain
• Intervention / Treatment: Drug: SBS-1000; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences Clinical Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SBS-1000; Investigational Product	Drug: SBS-1000; SBS-1000 administered as a single continuous IV infusion over 60 minutes; Other Names: arylepoxamide agonist
Placebo Comparator: Placebo; Normal saline (0.9% sodium chloride [NaCl])	Drug: Placebo; Normal saline (0.9% sodium chloride [NaCl]) administered as a single dose IV infusion over 60 minutes; Other Names: sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From start of infusion to 4 (±2) days after the last blood draw in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From start of infusion to 72 hours post-infusion

Collaborators and Investigators

• Sponsor: Sparian Biosciences, Inc
• Investigators: Study Director: Jeff Reich, MD, Sparian Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Arylepoxamide; SBS-1000; SBS1000; 6TM; AEAr Agonist
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Acute Pain; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: SBS1000-AP-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No