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Unknown

SBS-1000 for Safety Evaluation in Healthy Adults

Phase 1

Recruiting

Research Sponsored by Sparian Biosciences, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum body weight of at least 50.0 kg at Screening

Healthy adult male or female, aged 18 to 59 years, inclusive, at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of infusion to 72 hours post-infusion

Awards & highlights

Study Summary

This trial will test a new drug's safety & effectiveness in a controlled, randomized study. Results will help doctors decide best use.

Who is the study for?

Healthy adults aged 18-59, weighing at least 50 kg with a BMI of 18-33 can join this trial. They must not smoke, have no significant health issues, and agree to use contraception. Those with recent illnesses or on prescription drugs cannot participate.Check my eligibility

What is being tested?

The study is testing SBS-1000's safety and how well it's tolerated when given intravenously compared to a placebo in healthy volunteers. It's conducted in phases where doses are increased gradually.See study design

What are the potential side effects?

Since SBS-1000 is being tested for the first time in humans, potential side effects are unknown but may include typical drug reactions like pain at injection site, nausea, headache, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weigh at least 50 kg.

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I am a healthy adult between 18 and 59 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of infusion to 72 hours post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of infusion to 72 hours post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of infusion to 72 hours post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects with adverse events (AEs)

Secondary outcome measures

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SBS-1000Active Control1 Intervention

Investigational Product

Group II: PlaceboPlacebo Group1 Intervention

Normal saline (0.9% sodium chloride [NaCl])

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sparian Biosciences, IncLead Sponsor

Jeff Reich, MDStudy DirectorSparian Biosciences

Media Library

SBS-1000 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05721287 — Phase 1

Acute Pain Research Study Groups: SBS-1000, Placebo

Acute Pain Clinical Trial 2023: SBS-1000 Highlights & Side Effects. Trial Name: NCT05721287 — Phase 1

SBS-1000 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721287 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for participants that are eighty years and above?

"This clinical trial can only accept patients between the ages of 18 and 59, as stated in its eligibility requirements."

Answered by AI

Has the FDA sanctioned SBS-1000 for general use?

"As this is a Phase 1 clinical trial, the safety of SBS-1000 was given an initial rating of 1 due to lack of available data on efficacy and safety."

Answered by AI

Is this experiment in need of participants at the moment?

"Clinicaltrials.gov confirms that this study is currently enrolling participants, with its first posting on 30 January 2023 and the most recent update being 31 January of the same year."

Answered by AI

What is the scope of participants involved in this medical research?

"Yes, the information on clinicialtrials.gov indicates that this trial is actively enrolling patients. This study was first listed on January 30th 2023 and most recently updated on January 31st 2023. There are currently 56 participants being recruited from one location."

Answered by AI

Who is eligible to take part in this research investigation?

"This clinical trial seeks 56 volunteers between 18 and 59 years old, who suffer from acute pain. Those hoping to participate should meet the following requirements: A signed informed consent form (ICF), BMI within 18-33 kg/m^2 range, At least 50kg body weight, Willingness to comply with study procedures; For female participants an acceptable contraceptive method must be used; For male participants an acceptable contraceptive method is required; Clinically healthy at screening and admission; Non- or ex-smokers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721287.

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