Safety evaluation of nebulised HS4-20 physiologic aqueous chlorine aerosol Respiratory
Conditions
Interventions
Pulmonary administration of HS4-20 as an aerosol via a nebuliser.
The healthy volunteers were divided into three cohorts:
1. Two adults. Exposure escalation from 30 seconds increasing to 30 minutes.
Sponsors
Hypo-Stream Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers, no exclusions on basis of age or gender
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events measured using observation for the absence of abnormality and of coordination by a clinically trained investigator over a 30-minute period following administration. Follow-up was 7 days post-administration self-reporting. The final follow-up was over a 12-month period of self-reporting and investigator interview. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood pressure measured with an automatic upper arm cuff sphygmomanometer (Omron X3) at baseline (pre-administration), 30 seconds, 2, 5, 10, 20, 30 minutes post-administration in first and second cohorts, the third cohort was measured at 30 seconds, 5, 20, 30 minutes 2. Oxygen saturation measured by pulse oximeter (Braun Healthcare Pulse Oximeter 1) throughout the periods of exposure and for 30 minutes after cessation of administration | — |
Countries
England, United Kingdom
Contacts
Public ContactMyles Dakin
Outcome results
None listed