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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

Summary

This trial tests a nasal spray with stabilized isoamyl nitrite in healthy adults aged 18-45. The spray is absorbed through the nose and enters the bloodstream, where its effects are measured to ensure safety and understand its behavior.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Methemoglobin (MetHb) level
Related Serious Adverse Events (SAEs)
Secondary study objectives
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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
88 Previous Clinical Trials
550,146 Total Patients Enrolled
Department of Health and Human ServicesFED
230 Previous Clinical Trials
934,582 Total Patients Enrolled
Emergent BioSolutionsLead Sponsor
62 Previous Clinical Trials
937,424 Total Patients Enrolled
~13 spots leftby Sep 2025
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