A single ascending dose study of inhaled M3 in healthy adults
Research type
Research Study
Full title
A phase I, open label study in healthy volunteers to evaluate the safety and tolerability of inhaled nebulised HS4-20 solution
IRAS ID
1009024
Contact name
Paul Jenkins
Contact email
Sponsor organisation
Hypo-Stream Ltd
Research summary
This is a single site, two-part study of nebulised, inhaled HS4-20 in healthy male and female adult volunteers aged between 18-50 years old.
The study is designed to assess the safety and tolerability of an inhaled formulation of sodium hypochlorite (HS4-20) in healthy volunteers before proceeding to studies in patients with acute respiratory distress syndrome.
Part one follows a single ascending dose design and consists of 3 cohorts of 2 healthy subjects each receiving a single dose of nebulised HS4-20.
The following dose escalation pattern will be followed:
Dose schedule for Cohort 1: 5 minutes inhalation (0.05% solution)
Dose schedule for Cohort 2: 10 minutes inhalation (0.05% solution)
Dose schedule for Cohort 3: 20 minutes inhalation (0.05% solution)
There will be a minimum of 7 days between each cohort. Dosing can only begin when the previous cohort has completed treatment, and a dose escalation decision has been taken by the Dose Escalation Committee (DEC) to confirm the tolerability and safety results are acceptable.Part two follows a multiple ascending dose design and consists of 3 cohorts of 3 healthy participants each receiving a nebulised dose of HS4-20 2, 3 or 4 times a day for a total duration of 1 day. The dose at each administration (in terms of minutes of inhalation - X) will be based on results from part one (SAD study) and will lie in the range of 5-20 minutes inclusive.
The following dose escalation pattern will be followed:
Dose schedule for Cohort 4: 5-20 minutes inhalation x 2 (12 hours apart)
Dose schedule for Cohort 5: 5-20 minutes inhalation x 3 (6 hours apart)
Dose schedule for Cohort 6: 5-20 minutes inhalation x 4 (4 hours apart)
There will be a minimum of 7 days between each cohort. Dosing can only begin when the previous cohort has completed treatment, and a dose escalation decision has been taken by the Dose Escalation Committee (DEC) to confirm the tolerability and safety results are acceptable.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0004
Date of REC Opinion
1 Mar 2024
REC opinion
Further Information Unfavourable Opinion