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

NCT ID: NCT05721287

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-08-30

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.

Conditions

Pain; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SBS-1000

Investigational Product

Group Type: ACTIVE_COMPARATOR

SBS-1000

Intervention Type: DRUG

SBS-1000 administered as a single continuous IV infusion over 60 minutes

Placebo

Normal saline (0.9% sodium chloride \[NaCl\])

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline (0.9% sodium chloride \[NaCl\]) administered as a single dose IV infusion over 60 minutes

Interventions

SBS-1000

SBS-1000 administered as a single continuous IV infusion over 60 minutes

Intervention Type: DRUG

Placebo

Normal saline (0.9% sodium chloride \[NaCl\]) administered as a single dose IV infusion over 60 minutes

Intervention Type: DRUG

Other Intervention Names

arylepoxamide agonist; sodium chloride

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sparian Biosciences, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Reich, MD

Role: STUDY_DIRECTOR

Sparian Biosciences

Locations

Altasciences Clinical Kansas

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

SBS1000-AP-101

Identifier Type: -

Identifier Source: org_study_id