Stabilized Isoamyl Nitrite (SIAN) for Cyanide Poisoning

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cyanide PoisoningStabilized Isoamyl Nitrite (SIAN) - Drug
Eligibility
18 - 45
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Study Objectives

2 Primary · 27 Secondary · Reporting Duration: Through 360 minutes post-dose

Through 360 minutes post-dose
Methemoglobin (MetHb) level
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
PD Endpoint: The maximum change from baseline (Emax) of MetHb
PD Endpoint: Time of reaching Emax (TEmax) of MetHb
PD Endpoint: Time to recovery to baseline values of MetHb
PD Endpoint: t1/2 of MetHb
Through 59 minutes post-dose
PK Endpoint: AUC 0-t plus the additional area extrapolated to infinity (AUC 0-inf) of IAA
PK Endpoint: Apparent first order terminal elimination half-life (t 1/2) of IAA
PK Endpoint: Area under the concentration-time curve from time 0 to 10 minutes post-dose (AUC 0-10min) of IAA
PK Endpoint: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) of IAA
PK Endpoint: Maximum observed concentration (Cmax) of Isoamyl Alcohol (IAA metabolite)
PK Endpoint: Time at which Cmax occurs (Tmax) of IAA
Through 60 minutes Post-Dose
Safety Endpoint: Orthostatic Hypotension
Hour 8
PD Endpoint: Emax for HR (beats/min)
PD Endpoint: Emax for HR (heart rate) (beats/min)
PD Endpoint: Emax for SpO2 by pulse oximetry
PD Endpoint: TEmax for HR (beats/min)
PD Endpoint: TEmax for SpO2 by pulse oximetry
PD Endpoint: Time to recovery to baseline SpO2 (%)
PD Endpoint: Time to recovery to baseline for HR (beats/min)
Bronchial Provocation Tests
PD Endpoint: for BP maximum change from TEmax
PD Endpoint: for BP maximum change from baseline (Emax)
Through Day 8
Related Serious Adverse Events (SAEs)
Safety Endpoint: Adverse Events (AEs)
Safety Endpoint: Toxicity grade 1 or higher of clinical laboratories
Safety Endpoint: Toxicity grade 1 or higher of vital signs

Trial Safety

Trial Design

7 Treatment Groups

Cohort 3 SIAN
1 of 7
Cohort 1 SIAN
1 of 7
Cohort 2 SIAN
1 of 7
Cohort 4 SIAN
1 of 7
Cohort 6 SIAN
1 of 7
Cohort 7 SIAN
1 of 7
Cohort 5 SIAN
1 of 7

Experimental Treatment

70 Total Participants · 7 Treatment Groups

Primary Treatment: Stabilized Isoamyl Nitrite (SIAN) · No Placebo Group · Phase 1

Cohort 3 SIAN
Drug
Experimental Group · 1 Intervention: Stabilized Isoamyl Nitrite (SIAN) · Intervention Types: Drug
Cohort 1 SIAN
Drug
Experimental Group · 1 Intervention: Stabilized Isoamyl Nitrite (SIAN) · Intervention Types: Drug
Cohort 2 SIAN
Drug
Experimental Group · 1 Intervention: Stabilized Isoamyl Nitrite (SIAN) · Intervention Types: Drug
Cohort 4 SIAN
Drug
Experimental Group · 1 Intervention: Stabilized Isoamyl Nitrite (SIAN) · Intervention Types: Drug
Cohort 6 SIAN
Drug
Experimental Group · 1 Intervention: Stabilized Isoamyl Nitrite (SIAN) · Intervention Types: Drug
Cohort 7 SIAN
Drug
Experimental Group · 1 Intervention: Stabilized Isoamyl Nitrite (SIAN) · Intervention Types: Drug
Cohort 5 SIAN
Drug
Experimental Group · 1 Intervention: Stabilized Isoamyl Nitrite (SIAN) · 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: through 360 minutes post-dose

Who is running the clinical trial?

Department of Health and Human ServicesFED
201 Previous Clinical Trials
468,630 Total Patients Enrolled
Emergent BioSolutionsLead Sponsor
59 Previous Clinical Trials
937,390 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been inserted an IUD for 30 days or more before Day 1.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%