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

NCT05721287 | Completed Phase 1 FDA Drug

• 1 other identifier: SBS1000-AP-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Acute Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000

  From start of infusion to 72 hours post-infusion

Study Arms (2)

SBS-1000

ACTIVE COMPARATOR

Investigational Product

Drug: SBS-1000

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SBS-1000 DRUG

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

Also known as: arylepoxamide agonist

SBS-1000

Placebo DRUG

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

Also known as: sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sparian Biosciences, Inc: lead

Study Sites (1)

Altasciences Clinical Kansas

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jeff Reich, MD

  Sparian Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 10, 2023
• Study Start: January 30, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 30, 2023
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)