Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Stabilized Isoamyl Nitrite · 1 trial · 1 indication
Incidence of related SAEs
To determine the dose that will result in a 6-10% MetHb level
| Arm | Type | Description |
|---|---|---|
| Cohort 1 SIAN | EXPERIMENTAL | SIAN dose of 0.28 mg/kg (20 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 2 SIAN | EXPERIMENTAL | SIAN dose of 0.73 mg/kg (50 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 3 SIAN | EXPERIMENTAL | SIAN dose of 1.45 mg/kg (100 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 4 SIAN | EXPERIMENTAL | SIAN dose of 2.18 mg/kg (150 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 5 SIAN | EXPERIMENTAL | 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. |
| Cohort 6 SIAN | EXPERIMENTAL | 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. |
| Cohort 7 SIAN | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Stabilized Isoamyl Nitrite (SIAN) | DRUG | SIAN is comprised of isoamyl nitrite (IAN) stabilized with 4% by weight epoxidized linseed oil (ELSO) and administered by intranasal (IN) delivery as a nasal spray. A syringe-based spray device will be used to administer the SIAN product. This syringe-based spray device, consists of a Hamilton type syringe connected to a tip that functions as an atomizer, to provide an optimal spray plume for nasal absorption while minimizing exposure to lungs. |
Inclusion Criteria: 1. Able and willing to provide informed consent (and assent as applicable) voluntarily signed by subject/guardian/legally acceptable representative. 2. Generally healthy, in the opinion of the PI, medical history, physical examination, vital signs, ECG and laboratory assessments...
Stabilized Isoamyl Nitrite is an investigational small molecule being developed for the treatment of cyanide poisoning. It is formulated as a nasal spray and is currently in Phase 1 clinical development. The drug is intended to provide a potential therapeutic option for individuals exposed to cyanide.
Stabilized Isoamyl Nitrite is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is advancing this investigational drug through early-stage clinical development for the indication of cyanide poisoning.
Stabilized Isoamyl Nitrite is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under evaluation for its safety and tolerability in healthy volunteers.
Stabilized Isoamyl Nitrite has one completed Phase 1 clinical trial, identified as NCT05194358, titled 'Study of SIAN Nasal Spray in Healthy Adults.' This trial enrolled 47 participants in the United States and evaluated the drug in healthy volunteers aged 18 years and older.
Yes, Stabilized Isoamyl Nitrite is also referred to as SIAN in clinical research. The completed Phase 1 trial, NCT05194358, is titled 'Study of SIAN Nasal Spray in Healthy Adults,' confirming that SIAN is the alternative name used for this investigational drug in the study context.