Study of SIAN Nasal Spray in Healthy Adults

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05194358
Study type	Interventional
Source	Emergent BioSolutions
Contact
Status	Completed
Phase	Phase 1
Start date	December 21, 2021
Completion date	October 13, 2023

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