Back to resultsSafety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
Primary Purpose
Healthy Volunteers, Safety
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
SoftOx Inhaled Solution (SIS)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Has signed a written informed consent.
- Is 18 to 55 years of age (both inclusive). Women of child-bearing potential must be sexually abstinent or should agree to use effective contraceptive methods3 throughout the course of the study.
- Has a Body Mass Index (BMI) of 18.5-29.9 kg/m2 (both inclusive).
- Good health in the opinion of the Investigator based upon medical history, physical examination, vital signs, oxygen saturation, electrocardiogram (ECG), lung function, and laboratory profile of blood and urine.
- Is able to comply with the inhalation procedure of inhaling through the nose and exhaling through the mouth, in the opinion of the Investigator.
- Has negative urine drug screen and negative alcohol breath test on the day of screening and before the (first) administration of IMP.
Exclusion Criteria:
- Any surgical or medical condition, including findings in the medical history or in the pre-study assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct, or evaluation.
- Has had cancer within the last 10 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin.
- Intake of any prescription or non-prescription medication, or herbal products with known pharmacological effects (e.g., St. John's wort), within 2 weeks or 5 half-lives of the drug, whichever is longer, before the (first) administration of IMP with the exception of paracetamol, which is allowed up to 1000 mg QID dosed according to labelling as well as hormonal contraceptives and hormonal replacement therapy.
- Participation in the treatment phase of a clinical trial with an investigational new drug within one month before the (first) administration of IMP.
- Is a smoker or has used any form of nicotine product including e-cigarette, snuff, chewing tobacco, nicotine gum, etc., on a regular basis within three months before the (first) administration of IMP.
- Has a history (within the last two years) or is at present an abuser of alcohol or narcotics, or is a user of recreational drugs (e.g., cocaine).
- Has donated or lost > 400 mL blood within one month before the (first) administration of IMP.
- Has previously been randomised in this study.
- Is pregnant or lactating at screening or time of the (first) administration of IMP.
- Ascertained or presumptive allergy/hypersensitivity to SIS; history of anaphylaxis to drugs or serious allergic reactions leading to hospitalization or any other allergy reaction in general, which the Investigator considers may affect the safety of the subject and/or outcome of the study.
- Inability to communicate or cooperate with the Investigator (e.g., language problem, illiteracy, poor mental status) or to comply with the requirements of the study.
- Legal incapacity or limited legal capacity.
- Is considered by the Investigator, unsuitable to participate in the study for any other reason.
Sites / Locations
- DanTrials ApS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Single dose of up to 5 mL nebulised SIS @ 25 ppm/placebo
Single dose of up to 5 mL nebulised SIS @ 50 ppm/placebo
Single dose of up to 5 mL nebulised SIS @ 100 ppm/placebo
OD dosing of up to 5 mL nebulised SIS @ x ppm/placebo for 5 days
OD dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 5 days
BID dosing of up to 5 mL nebulised SIS @ y ppm/placebo, for 4 days + morning dose on Day 5
QID dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 4 days + morning dose on Day 5
Arm Description
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.
Outcomes
Primary Outcome Measures
Occurrence of adverse events (AEs).
Severity of adverse events (AEs).
Change from baseline in forced expiratory volume in 1 second (FEV1)
Change from baseline in oxygen saturation measured by pulse oximetry
Change from baseline in local tolerability
Subjects will be asked to complete a brief questionnaire regarding symptoms (irritation, burning sensation/pain, coughing, sneezing, or other) from the mouth, nose, and respiratory tract.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05188638
Brief Title
Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
Official Title
Single-centre, Randomised, Placebo-controlled, and Double-blinded First-in-human Clinical Study Investigating the Safety and Tolerability of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
April 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SoftOx Solutions AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single dose of up to 5 mL nebulised SIS @ 25 ppm/placebo
Arm Type
Experimental
Arm Title
Single dose of up to 5 mL nebulised SIS @ 50 ppm/placebo
Arm Type
Experimental
Arm Title
Single dose of up to 5 mL nebulised SIS @ 100 ppm/placebo
Arm Type
Experimental
Arm Title
OD dosing of up to 5 mL nebulised SIS @ x ppm/placebo for 5 days
Arm Type
Experimental
Arm Description
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.
Arm Title
OD dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 5 days
Arm Type
Experimental
Arm Title
BID dosing of up to 5 mL nebulised SIS @ y ppm/placebo, for 4 days + morning dose on Day 5
Arm Type
Experimental
Arm Title
QID dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 4 days + morning dose on Day 5
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SoftOx Inhaled Solution (SIS)
Intervention Description
SIS consists of the active compound, hypochlorous acid (HOCl). Concentrations of SIS refer to the concentration of HOCl in parts per million (ppm).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile isotonic saline
Primary Outcome Measure Information:
Title
Occurrence of adverse events (AEs).
Time Frame
From the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
Title
Severity of adverse events (AEs).
Time Frame
From the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
Title
Change from baseline in forced expiratory volume in 1 second (FEV1)
Time Frame
From 30 minutes after the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
Title
Change from baseline in oxygen saturation measured by pulse oximetry
Time Frame
From the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
Title
Change from baseline in local tolerability
Description
Subjects will be asked to complete a brief questionnaire regarding symptoms (irritation, burning sensation/pain, coughing, sneezing, or other) from the mouth, nose, and respiratory tract.
Time Frame
Immediately after completion of the inhalation to 2 or 3 days after the last administration of IMP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Has signed a written informed consent.
Is 18 to 55 years of age (both inclusive). Women of child-bearing potential must be sexually abstinent or should agree to use effective contraceptive methods3 throughout the course of the study.
Has a Body Mass Index (BMI) of 18.5-29.9 kg/m2 (both inclusive).
Good health in the opinion of the Investigator based upon medical history, physical examination, vital signs, oxygen saturation, electrocardiogram (ECG), lung function, and laboratory profile of blood and urine.
Is able to comply with the inhalation procedure of inhaling through the nose and exhaling through the mouth, in the opinion of the Investigator.
Has negative urine drug screen and negative alcohol breath test on the day of screening and before the (first) administration of IMP.
Exclusion Criteria:
Any surgical or medical condition, including findings in the medical history or in the pre-study assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct, or evaluation.
Has had cancer within the last 10 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin.
Intake of any prescription or non-prescription medication, or herbal products with known pharmacological effects (e.g., St. John's wort), within 2 weeks or 5 half-lives of the drug, whichever is longer, before the (first) administration of IMP with the exception of paracetamol, which is allowed up to 1000 mg QID dosed according to labelling as well as hormonal contraceptives and hormonal replacement therapy.
Participation in the treatment phase of a clinical trial with an investigational new drug within one month before the (first) administration of IMP.
Is a smoker or has used any form of nicotine product including e-cigarette, snuff, chewing tobacco, nicotine gum, etc., on a regular basis within three months before the (first) administration of IMP.
Has a history (within the last two years) or is at present an abuser of alcohol or narcotics, or is a user of recreational drugs (e.g., cocaine).
Has donated or lost > 400 mL blood within one month before the (first) administration of IMP.
Has previously been randomised in this study.
Is pregnant or lactating at screening or time of the (first) administration of IMP.
Ascertained or presumptive allergy/hypersensitivity to SIS; history of anaphylaxis to drugs or serious allergic reactions leading to hospitalization or any other allergy reaction in general, which the Investigator considers may affect the safety of the subject and/or outcome of the study.
Inability to communicate or cooperate with the Investigator (e.g., language problem, illiteracy, poor mental status) or to comply with the requirements of the study.
Legal incapacity or limited legal capacity.
Is considered by the Investigator, unsuitable to participate in the study for any other reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Burton, MD; PhD
Organizational Affiliation
SoftOx Solutions A/S
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David P Sonne, MD; PhD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
DanTrials ApS
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
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