Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05194358 | Study of SIAN Nasal Spray in Healthy Adults | PHASE1 | COMPLETED | 47 | — | — | Dec 21, 2021 | Oct 13, 2023 | Jun 3, 2025 | 2 | United States |
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...