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

NCT05721287 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-11-26

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

SBS-1000

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Sparian Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Jeff Reich, MD · Sparian Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-08-15
Completion
2023-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721287 on ClinicalTrials.gov