SBS-1000 for Acute Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Altasciences Clinical Kansas, Overland Park, KSAcute Pain+1 MoreSBS-1000 - Drug
Eligibility
18 - 59
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Acute Pain
  • Pain

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: From start of infusion to 72 hours post-infusion

From start of infusion to 4 (±2) days after the last blood draw in the study
Number of subjects with adverse events (AEs)
Hour 72
Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000

Trial Safety

Trial Design

2 Treatment Groups

SBS-1000
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

56 Total Participants · 2 Treatment Groups

Primary Treatment: SBS-1000 · Has Placebo Group · Phase 1

SBS-1000
Drug
ActiveComparator Group · 1 Intervention: SBS-1000 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from start of infusion to 72 hours post-infusion

Who is running the clinical trial?

Sparian Biosciences, IncLead Sponsor
Jeff Reich, MDStudy DirectorSparian Biosciences

Eligibility Criteria

Age 18 - 59 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your weight is within a certain range based on your height (BMI between 18.0 and 33.0 kg/m^2).
You have never smoked or you used to smoke but have quit.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.