RT Journal Article
SR Electronic
T1 Safety of ascending single and multiple doses of inhaled SIS, an isotonic aqueous solution of sodium hypochlorite, in healthy subjects
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 4333
DO 10.1183/13993003.congress-2022.4333
VO 60
IS suppl 66
A1 C Burton
A1 T Balchen
A1 L Wilki-Kurtzhals
A1 N Sjögren
A1 T Bjarnsholt
A1 E Jørgensen
A1 D P Sonne
YR 2022
UL http://erj.ersjournals.com/content/60/suppl_66/4333.abstract
AB Background: SIS is a novel aqueous formulation of sodium hypochlorite (NaOCl), which is present as hypochlorous acid (HOCl), a biological oxidant with broad spectrum antimicrobial activity in vitro.Objectives & Methods: This single-centre, first-in-human, randomised, double-blind, placebo-controlled study was designed to explore the safety and tolerability of ascending single and multiple doses of inhaled SIS (NCT05188638). Subjects were randomised 3:1 to receive SIS formulations (HOCl concentrations 25 – 100 µg/mL) in single or multiple daily administrations (once to four times daily) for 5 days, or a matching placebo regimen.Results: A total of N = 57 healthy subjects (age 27 ± 6 years, 60% male, 84% Caucasian, 98% not Hispanic or Latino, BMI 23.9 ± 2.9 kg/m2) were randomised to receive SIS (n = 43) or placebo (n = 14). One subject withdrew voluntarily from the study due to personal choice, unrelated to study treatment. There were no reported serious adverse events. A total of 18 adverse events were reported in 15 subjects (27.9% subjects receiving SIS and 21.4% subjects receiving placebo). Adverse events were predominantly mild. Solicited reporting of primarily mild local tolerability showed a dose-response relationship in SIS treated groups (0% assessments in the single dose 25 µg/mL formulation group to 14.2% assessments in the four times daily 100 µg/mL formulation group over 5 days). No dose-response effects on spirometry were observed.Conclusions: SIS at concentrations of up to 100 µg/mL administered four times daily was safe and well tolerated, in this study population of healthy volunteers.FootnotesCite this article as Eur Respir J 2022; 60: Suppl. 66, 4333.This article was presented at the 2022 ERS International Congress, in session “-”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).