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

Primary Purpose

Pain, Acute Pain

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SBS-1000
Placebo
Sponsored by
Sparian Biosciences, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Arylepoxamide, Safety, Tolerability, SBS-1000, SBS1000, 6TM, AEAr Agonist

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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 Exclusion Criteria: 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 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

Sites / Locations

  • Altasciences Clinical KansasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SBS-1000

Placebo

Arm Description

Investigational Product

Normal saline (0.9% sodium chloride [NaCl])

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2023
Last Updated
January 31, 2023
Sponsor
Sparian Biosciences, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05721287
Brief Title
A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sparian Biosciences, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute Pain
Keywords
Arylepoxamide, Safety, Tolerability, SBS-1000, SBS1000, 6TM, AEAr Agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBS-1000
Arm Type
Active Comparator
Arm Description
Investigational Product
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline (0.9% sodium chloride [NaCl])
Intervention Type
Drug
Intervention Name(s)
SBS-1000
Other Intervention Name(s)
arylepoxamide agonist
Intervention Description
SBS-1000 administered as a single continuous IV infusion over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sodium chloride
Intervention Description
Normal saline (0.9% sodium chloride [NaCl]) administered as a single dose IV infusion over 60 minutes
Primary Outcome Measure Information:
Title
Number of subjects with adverse events (AEs)
Description
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
Time Frame
From start of infusion to 4 (±2) days after the last blood draw in the study
Secondary Outcome Measure Information:
Title
Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000
Description
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
Time Frame
From start of infusion to 72 hours post-infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lissette Altoro, MD
Phone
913-696-1601
Email
laltoro@altasciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Reich, MD
Organizational Affiliation
Sparian Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Altasciences Clinical Kansas
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Kankam, MD
Phone
913-696-1601
Email
Regulatory@altasciences.com
First Name & Middle Initial & Last Name & Degree
Martin Kankam, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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