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Vasodilator

Stabilized Isoamyl Nitrite (SIAN) for Cyanide Poisoning

Phase 1
Waitlist Available
Research Sponsored by Emergent BioSolutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 360 minutes post-dose
Awards & highlights

Study Summary

This trial is testing a new nasal spray made from a chemical called isamyl nitrite. They want to see if it's safe and how it affects the body.

Eligible Conditions
  • Cyanide Poisoning

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 360 minutes post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 360 minutes post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Methemoglobin (MetHb) level
Related Serious Adverse Events (SAEs)
Secondary outcome measures
PD Endpoint: AUC0-t of MetHb
PD Endpoint: Area under the effect curve (AUEC(0-t)) of the fraction of MetHb (%)
PD Endpoint: Cmax of MetHb
+23 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7 SIANExperimental Treatment1 Intervention
SIAN dose of 4.35 mg/kg (300 μL) will be administered in two syringe-based spray devices, each containing 150 μL, with dose administered in left then right nostril, one device per nostril.
Group II: Cohort 6 SIANExperimental Treatment1 Intervention
SIAN dose of 3.63 mg/kg (250 μL) will be administered in two syringe-based spray devices, each containing 125 μL, with dose administered in left then right nostril, one device per nostril.
Group III: Cohort 5 SIANExperimental Treatment1 Intervention
SIAN dose of 2.90 mg/kg (200 μL) will be administered in two syringe-based spray devices, each containing 100 μL, with dose administered in left then right nostril, one device per nostril. For doses of 2.90 milligram/kilogram (200 microliter) and higher, the dose will be split equally between the two nostrils to avoid drug overflow from the nose (using two syringe-based spray devices one immediately followed by the other). Lower doses will be administered by a single device to one nostril.
Group IV: Cohort 4 SIANExperimental Treatment1 Intervention
SIAN dose of 2.18 mg/kg (150 μL) will be administered from a single syringe-based spray device into left nostril.
Group V: Cohort 3 SIANExperimental Treatment1 Intervention
SIAN dose of 1.45 mg/kg (100 μL) will be administered from a single syringe-based spray device into left nostril.
Group VI: Cohort 2 SIANExperimental Treatment1 Intervention
SIAN dose of 0.73 mg/kg (50 μL) will be administered from a single syringe-based spray device into left nostril.
Group VII: Cohort 1 SIANExperimental Treatment1 Intervention
SIAN dose of 0.28 mg/kg (20 μL) will be administered from a single syringe-based spray device into left nostril.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stabilized Isoamyl Nitrite (SIAN)
2021
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Department of Health and Human ServicesFED
223 Previous Clinical Trials
928,175 Total Patients Enrolled
Emergent BioSolutionsLead Sponsor
61 Previous Clinical Trials
937,437 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must one meet to participate in this medical experiment?

"This trial is seeking to recruit 70 participants with toxic effects of hydrocyanic acid and cyanides between the ages of 18-45. To be accepted, these criteria must be met."

Answered by AI

Is the age cap for this trial exceeding sixty years?

"As per the parameters set forth by this clinical trial, it is mandatory for participants to be at least 18 years of age and no older than 45."

Answered by AI

Could you outline the primary goals of this investigation?

"Emergent BioSolutions, the trial sponsor, has stated that the primary indicator to measure over Through Day 8 is Methemoglobin (MetHb) level. Additionally, this study will analyse various secondary outcomes such as toxicity grade 1 or higher of clinical laboratories incidence rates, time at which Cmax occurs (Tmax) of IAA assessment and Emax for HR (heart rate) beat per minute estimation."

Answered by AI

Is enrollment still available for this trial?

"Per clinicaltrials.gov, this research study is actively looking for participants with the trial having been first posted on December 21st 2021 and last updated October 21st 2022."

Answered by AI

What is the enrollment size of this medical trial?

"Affirmative. Data available on clinicaltrials.gov confirms that this trial, which was initially posted in December of 2021, is currently recruiting individuals to participate. 70 prospective patients are needed from two different sites."

Answered by AI

Has the FDA sanctioned Stabilized Isoamyl Nitrite (SIAN) for use?

"Due to the limited data present on SIAN's efficacy and safety, our Power team assigned this medication a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~14 spots leftby Mar 2025