drugset / Trial / NCT05194358
Study of SIAN Nasal Spray in Healthy Adults
Phase 1
Completed
47 enrolled
Emergent BioSolutions
Biomedical Advanced Research and Development Authority · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of Stabilized Isoamyl Nitrite (SIAN) nasal spray in healthy subjects.
Timeline
- Start
- 2021-12-21
- Primary completion
- 2023-09-29
- Completion
- 2023-10-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | isoamyl nitrite | Unknown | 0.28 mg/kg | Intranasal |
| Subject | isoamyl nitrite | Unknown | 0.73 mg/kg | Intranasal |
| Subject | isoamyl nitrite | Unknown | 1.45 mg/kg | Intranasal |
| Subject | isoamyl nitrite | Unknown | 2.18 mg/kg | Intranasal |
| Subject | isoamyl nitrite | Unknown | 2.9 mg/kg | Intranasal |
| Subject | isoamyl nitrite | Unknown | 3.63 mg/kg | Intranasal |
| Subject | isoamyl nitrite | Unknown | 4.35 mg/kg | Intranasal |