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

Sponsor

Sparian Biosciences, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05721287

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jan 30, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jun 1, 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 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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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