Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
Status:
Recruiting
Trial end date:
2022-03-21
Target enrollment:
Participant gender:
Summary
Background:
This first-in-human study will investigate the safety and tolerability of single and multiple
doses of nebulised SoftOx Inhalation Solution (SIS) delivered via a jet nebuliser to healthy
subjects.
Objectives:
The objective of the current study is to assess the safety and tolerability of single and
multiple ascending doses of nebulised SIS in healthy subjects.
Eligibility:
Subjects are eligible to participate in this study if they are healthy, between 18 and 55
years of age, and have a Body Mass Index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2.
Subjects are not eligible to participate in this study if they have recently participated in
another clinical trial or have donated blood, have a medical condition or a history of drug
hypersensitivity, are using concomitant medication, or have a positive drugs of abuse test.
Design:
A randomised, double-blind, and placebo-controlled trial. Subjects will be enrolled into one
of three single dose groups or into one of four multiple dose groups. The two first multiple
dose groups will be dosed once daily (OD) for five days. The two last multiple dose groups
will be dosed twice daily (BID) for four days plus a morning dose on Day 5, or four times
daily (QID) for four days plus a morning dose on Day 5, respectively.
The investigational medicinal product (SIS or placebo; IMP) will be delivered via a jet
nebuliser and inhaled through a mask over a period of up to 15 minutes.
Each treatment group will comprise eight subjects who will be randomised to receive SIS or
placebo in a 3:1 ratio.
A Safety Monitoring Committee (SMC) will review the safety and tolerability data from all
preceding groups and decide whether the planned next dose regimen is acceptable prior to
initiating the dosing in a new dose group.
The dose to be administered in the multiple dose groups will depend on the results obtained
in the single dose groups and will be decided by the SMC. The dose tested in the first
multiple dose group will be the second highest well-tolerated single dose or lower.