NCT05194358

Study of SIAN Nasal Spray in Healthy Adults

Phase 1, Open Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Stabilized Isoamyl Nitrite (SIAN) Nasal Spray in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, open label, single ascending dose (SAD) study of Stabilized Isoamyl Nitrite (SIAN) nasal spray to assess safety, PK and PD. The study will consist of seven cohorts, with up to 10 subjects planned per cohort, for a total of 70 subjects. Each cohort will include 10 healthy male or non-pregnant female subjects, aged 18 to 45 years inclusive. There will be a screening period from Day -28 to Day -2 for all study subjects. Subjects will stay overnight at the site the day prior to dosing (Day -1) and the day of dosing (Day 1). They will be evaluated until 24 hours after dosing (Day 2) prior to discharge from the phase 1 clinic. Subjects will return for an End of Study Visit at Day 8 after dosing. Within cohorts one and two, the first two subjects will be dosed as sentinels, while cohorts three to seven will dose the first three subjects as sentinels. Upon completion of the Day 8 (end of study/early withdrawal) visit, safety data, including clinical and laboratory data, and raw PD/PK data will be reviewed by the Principal Investigator (PI) and Medical Monitor (MM) and Safety Monitoring Committee (SMC). If exposure is evident based on raw IAA PK data and PD response signals are detected, the remaining subjects (eight subjects for cohorts one and two and seven subjects for cohorts three to seven) will be dosed. If no exposure and/or PD response signals are detected during sentinel dosing, escalation to the next cohort may be permitted by the SMC. For cohorts where all 10 subjects are dosed, the SMC will review the entire cohort data through each subject's Day 8 visit and provide a recommendation on either, (a) dose escalation to the next cohort, (b) lowering the next dose level, or (c) stopping enrollment based on dose-limiting toxicity. Each new cohort will be dosed following the same procedure as the prior cohort.

Conditions

• Cyanide Poisoning

Interventions

Type	Name	Description
DRUG	Stabilized Isoamyl Nitrite (SIAN)	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.

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-09-29
• Completion: 2023-10-13
• First posted: 2022-01-18
• Last updated: 2025-06-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study