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

• ClinicalTrials.gov Identifier: NCT05721287
• Recruitment Status: Recruiting
• First Posted: February 10, 2023
• Last Update Posted: February 10, 2023
• Sponsor: Sparian Biosciences, Inc
• Information provided by (Responsible Party): Sparian Biosciences, Inc

Study Description

Brief Summary:

This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.

Condition or disease	Intervention/treatment	Phase
Pain; Acute Pain	Drug: SBS-1000; Drug: Placebo	Phase 1

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 30, 2023
• Estimated Primary Completion Date: October 2023
• Estimated Study Completion Date: June 2024

Arms and Interventions

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 Name: 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 Name: sodium chloride

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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 ]
   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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Lissette Altoro, MD; 913-696-1601; laltoro@altasciences.com

Locations

United States, Kansas

Altasciences Clinical Kansas; Recruiting

Overland Park, Kansas, United States, 66212

Contact: Martin Kankam, MD 913-696-1601 Regulatory@altasciences.com

Principal Investigator: Martin Kankam, MD

Sponsors and Collaborators

Sparian Biosciences, Inc

Investigators

• Study Director: Jeff Reich, MD; Sparian Biosciences

More Information

• Responsible Party: Sparian Biosciences, Inc
• ClinicalTrials.gov Identifier: NCT05721287
• Other Study ID Numbers: SBS1000-AP-101
• First Posted: February 10, 2023
• Last Update Posted: February 10, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sparian Biosciences, Inc:

Arylepoxamide; Safety; Tolerability; SBS-1000; SBS1000; 6TM; AEAr Agonist

Additional relevant MeSH terms:

Acute Pain; Pain; Neurologic Manifestations