Healthy VolunteersPhase 1NCT05188638

Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects

A Phase 1 study testing SoftOx Inhaled Solution (SIS) in people with Healthy Volunteers and Safety, run by SoftOx Solutions AS at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Safety
What is being tested?: SoftOx Inhaled Solution (SIS)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteDenmark
Study dates: 8 Oct 2021to 13 Apr 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

DanTrials ApS
Copenhagen, DK-2400

Other trials in Denmark

About this study

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

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.

Conditions: Healthy Volunteers, Safety
Being tested: SoftOx Inhaled Solution (SIS), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SoftOx Inhaled Solution (SIS)Drug
SIS consists of the active compound, hypochlorous acid (HOCl). Concentrations of SIS refer to the concentration of HOCl in parts per million (ppm).
PlaceboDrug
Sterile isotonic saline

Study groups in NCT05188638
Study group	Role	What they receive
Single dose of up to 5 mL nebulised SIS @ 25 ppm/placebo	Experimental	Not described Receives: Drug: SoftOx Inhaled Solution (SIS); Drug: Placebo
Single dose of up to 5 mL nebulised SIS @ 50 ppm/placebo	Experimental	Not described Receives: Drug: SoftOx Inhaled Solution (SIS); Drug: Placebo
Single dose of up to 5 mL nebulised SIS @ 100 ppm/placebo	Experimental	Not described Receives: Drug: SoftOx Inhaled Solution (SIS); Drug: Placebo
OD dosing of up to 5 mL nebulised SIS @ x ppm/placebo for 5 days	Experimental	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. Receives: Drug: SoftOx Inhaled Solution (SIS); Drug: Placebo
OD dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 5 days	Experimental	Not described Receives: Drug: SoftOx Inhaled Solution (SIS); Drug: Placebo
BID dosing of up to 5 mL nebulised SIS @ y ppm/placebo, for 4 days + morning dose on Day 5	Experimental	Not described Receives: Drug: SoftOx Inhaled Solution (SIS); Drug: Placebo
QID dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 4 days + morning dose on Day 5	Experimental	Not described Receives: Drug: SoftOx Inhaled Solution (SIS); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of adverse events (AEs).
Measured: From the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
Severity of adverse events (AEs).
Measured: From the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
Change from baseline in forced expiratory volume in 1 second (FEV1)
Measured: From 30 minutes after the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
Change from baseline in oxygen saturation measured by pulse oximetry
Measured: From the start of the first administration of IMP to 2 or 3 days after the last administration of IMP
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.
Measured: Immediately after completion of the inhalation to 2 or 3 days after the last administration of IMP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202113 Apr 2022

First posted12 Jan 2022
Study start8 Oct 2021
Primary completion13 Apr 2022
Study completion13 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05188638
Sponsor's protocol ID: SIS-01
Other IDs: 2020-004462-19
Status last verified: Apr 2022
First submitted: 9 Dec 2021
Last updated: 20 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05188638
Acronym / sponsor ID: SIS-01
Conditions: Healthy Volunteers, Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: SoftOx Solutions ASIndustry (pharma, biotech, devices)
Study start: 8 Oct 2021 (actual)
Primary completion: 13 Apr 2022 (actual)
Study completion: 13 Apr 2022 (actual)
First posted: 12 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Design:

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Single dose of up to 5 mL nebulised SIS @ 25 ppm/placebo	Experimental	Drug: SoftOx Inhaled Solution (SIS), Drug: Placebo
Single dose of up to 5 mL nebulised SIS @ 50 ppm/placebo	Experimental	Drug: SoftOx Inhaled Solution (SIS), Drug: Placebo
Single dose of up to 5 mL nebulised SIS @ 100 ppm/placebo	Experimental	Drug: SoftOx Inhaled Solution (SIS), Drug: Placebo
OD dosing of up to 5 mL nebulised SIS @ x ppm/placebo for 5 days	Experimental	Drug: SoftOx Inhaled Solution (SIS), Drug: PlaceboThe 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.
OD dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 5 days	Experimental	Drug: SoftOx Inhaled Solution (SIS), Drug: Placebo
BID dosing of up to 5 mL nebulised SIS @ y ppm/placebo, for 4 days + morning dose on Day 5	Experimental	Drug: SoftOx Inhaled Solution (SIS), Drug: Placebo
QID dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 4 days + morning dose on Day 5	Experimental	Drug: SoftOx Inhaled Solution (SIS), Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SoftOx Inhaled Solution (SIS)SIS consists of the active compound, hypochlorous acid (HOCl). Concentrations of SIS refer to the concentration of HOCl in parts per million (ppm).	Drug	BID dosing of up to 5 mL nebulised SIS @ y ppm/placebo, for 4 days + morning dose on Day 5, 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, QID dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 4 days + morning dose on Day 5, Single dose of up to 5 mL nebulised SIS @ 100 ppm/placebo, Single dose of up to 5 mL nebulised SIS @ 25 ppm/placebo, Single dose of up to 5 mL nebulised SIS @ 50 ppm/placebo
PlaceboSterile isotonic saline	Drug	BID dosing of up to 5 mL nebulised SIS @ y ppm/placebo, for 4 days + morning dose on Day 5, 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, QID dosing of up to 5 mL nebulised SIS @ y ppm/placebo for 4 days + morning dose on Day 5, Single dose of up to 5 mL nebulised SIS @ 100 ppm/placebo, Single dose of up to 5 mL nebulised SIS @ 25 ppm/placebo, Single dose of up to 5 mL nebulised SIS @ 50 ppm/placebo

Primary outcome

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
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
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
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
Change from baseline in local tolerability
Time frame: Immediately after completion of the inhalation to 2 or 3 days after the last administration of IMP
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher M Burton, MD; PhD study director

SoftOx Solutions A/S

David P Sonne, MD; PhD principal investigator

Bispebjerg Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SoftOx Inhaled Solution (SIS) in people with Healthy Volunteers and Safety, run by SoftOx Solutions AS at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05188638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.