Heart FailurePhase 1SUBCUT-HF INCT04846816
A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
A Phase 1 study testing SQIN-01 in people with Heart Failure, run by SQ Innovation, Inc. at 1 site in United Kingdom.
Trial summary
This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SQIN-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2021to 13 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Written informed consent
- Male or female ≥18 years of age
- Meet ESC criteria for diagnosis of HF(4)
- Inpatient with a primary diagnosis of HF requiring treatment with intravenous furosemide at dose
Who cannot join
- • Unable to consent to inclusion in study due to lack of capacity
- Requiring treatment with intravenous furosemide at dose >200 mg per day as determined by the usual care team
- Current inotropes, vasopressors or intra-aortic balloon pump therapy
- Concomitant use of diuretics in 12 hours preceding administration of study drug with SQIN-Infusor
- Systolic blood pressure (SBP) <90 mmHg
- Pregnancy or breastfeeding
Show all 16Show fewer
- Left sided valve disease with planned surgery or percutaneous intervention
- Type 1 myocardial infarction during index hospitalisation (type 2 myocardial infarctions are allowed)(5)
- Any surgical or medical condition which prevents patient from ambulation during the infusion
- Renal impairment, defined as eGFR < 30 mL/min/1.73 m2 at screening.
- Patient on active cardiac transplant waiting list
- Potassium <3.0 mmol/L
- Potassium >6.0 mmol/L
- Sodium <125 mmol/L
- Any contraindications for furosemide administration as per furosemide SmPC
- Any surgical or medical conditions, which in the opinion of the investigator may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
Glasgow, Glasgow, G51 4TF
About this study
Official title: An Open Label, Single Dose Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure: a Phase I Clinical Trial
This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF.
Read the detailed description
The investigational product consists of a novel higher concentration (30mg/mL) furosemide formulation developed for subcutaneous administration and a novel patch pump placed on the abdominal skin. This trial will investigate the on body performance of novel patch pump delivering the novel formulation. Study parameters include pharmacokinetic measurements and diuretic response following subcutaneous administration of 80mg of furosemide solution in 2.7mL in patients with heart failure (HF). Recruitment will be restricted to 1 site with a recruitment target of 20 patients. All trial related activities will be conducted in an inpatient environment.
- Conditions
- Heart Failure
- Being tested
- SQIN-01
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQIN-01Combination product
The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide.
| Study group | Role | What they receive |
|---|---|---|
| SQIN-01 | Experimental | The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide. Receives: Combination Product: SQIN-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01)
To investigate the safety, tolerability, efficacy, and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01). Safety as determined by treatment emergent adverse events (TEAEs), (including serious adverse events [SAEs]) and adverse drug events (ADEs) (including serious adverse drug events [SADEs]).
Measured: 0-24 hours after infusion start
Infusion Site Pain
Measured on a scale of 0 = no pain to 10 = maximal pain
Measured: Baseline, 5 hours after infusion start, 24 hours after infusion start, and maximum pain during 5 hour infusion
Any Device Failures
Any device failures (eg, adhesive failure and drug delivery failure)
Measured: During 5 hour infusion
Plasma Furosemide Concentration
Plasma furosemide concentration (at 0 min, pre-treatment)
Measured: At baseline
Plasma Furosemide Concentration
Plasma furosemide concentration
Measured: At 60 minutes
Plasma Furosemide Concentration
Plasma furosemide concentration
Measured: At 240 minutes
Secondary outcomes (4)
Urine Volume
Cumulative urine volume (ml) in urine collected over 8 hours from the start of SQIN-Furosemide infusion
Measured: 8 hours
Sodium Concentration in Urine
Spot sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion
Measured: 8 hours
Presence of Local Skin Reactions
Presence of local skin reactions on examination (Erythma/Edema Score: 0 = No skin response; ½ = Questionable or faint, indistinct erythema; 1 = Well-defined erythema; 2 = Erythema with slight to moderate edema; 3 = Vesicles (small blisters) or papules (small, circumscribed elevations); 4 = Bullous (large blister), spreading, or other severe reaction.)
Measured: Baseline, 5 hours post infusion start, and 24 hours post infusion start
Patient Acceptability
Patient acceptability using System Usability Scale - from 0 to 100 with a lower number correlating to poor usability and a higher number correlating to better usability by patients.
Measured: 5 hours post infusion start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start6 May 2021
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SQ Innovation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Glasgow, NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor
- Investigators
- Mark Petrie, MBChB, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846816
- Sponsor's protocol ID
- GN18CA193
- Acronym
- SUBCUT-HF I
- Status last verified
- Oct 2024
- First submitted
- 12 Apr 2021
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to publish
Publications
Osmanska J, Brooksbank K, Docherty KF, Robertson S, Wetherall K, McConnachie A, Hu J, Gardner RS, Clark AL, Squire IB, Kalra PR, Jhund PS, Muntendam P, McMurray JJV, Petrie MC, Campbell RT. A novel, small-volume subcutaneous furosemide formulation delivered by an abdominal patch infusor device in patients with heart failure: results of two phase I studies. Eur Heart J Cardiovasc Pharmacother. 2024 Jan 5;10(1):35-44. doi: 10.1093/ehjcvp/pvad073.
PubMed 37804170
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure: a Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT04846816
- Acronym / sponsor ID
- SUBCUT-HF I / GN18CA193
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SQ Innovation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Glasgow, NHS Greater Glasgow and Clyde
- Study start
- 6 May 2021 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF.
Detailed description
The investigational product consists of a novel higher concentration (30mg/mL) furosemide formulation developed for subcutaneous administration and a novel patch pump placed on the abdominal skin. This trial will investigate the on body performance of novel patch pump delivering the novel formulation. Study parameters include pharmacokinetic measurements and diuretic response following subcutaneous administration of 80mg of furosemide solution in 2.7mL in patients with heart failure (HF). Recruitment will be restricted to 1 site with a recruitment target of 20 patients. All trial related activities will be conducted in an inpatient environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide.
| Arm | Type | Receives |
|---|---|---|
| SQIN-01 | Experimental | Combination Product: SQIN-01The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Written informed consent
Key exclusion criteria (16 listed)
- • Unable to consent to inclusion in study due to lack of capacity
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 |
|---|---|---|
| SQIN-01The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide. | Combination product | SQIN-01 |
Primary outcome
To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01)
Time frame: 0-24 hours after infusion start
To investigate the safety, tolerability, efficacy, and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01). Safety as determined by treatment emergent adverse events (TEAEs), (including serious adverse events [SAEs]) and adverse drug events (ADEs) (including serious adverse drug events [SADEs]).
Infusion Site Pain
Time frame: Baseline, 5 hours after infusion start, 24 hours after infusion start, and maximum pain during 5 hour infusion
Measured on a scale of 0 = no pain to 10 = maximal pain
Any Device Failures
Time frame: During 5 hour infusion
Any device failures (eg, adhesive failure and drug delivery failure)
Plasma Furosemide Concentration
Time frame: At baseline
Plasma furosemide concentration (at 0 min, pre-treatment)
Plasma Furosemide Concentration
Time frame: At 60 minutes
Plasma furosemide concentration
Plasma Furosemide Concentration
Time frame: At 240 minutes
Plasma furosemide concentration
4 secondary outcomes
Urine Volume
Time frame: 8 hours
Sodium Concentration in Urine
Time frame: 8 hours
Presence of Local Skin Reactions
Time frame: Baseline, 5 hours post infusion start, and 24 hours post infusion start
Patient Acceptability
Time frame: 5 hours post infusion start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37804170Osmanska J, Brooksbank K, Docherty KF, Robertson S, Wetherall K, McConnachie A, Hu J, Gardner RS, Clark AL, Squire IB, Kalra PR, Jhund PS, Muntendam P, McMurray JJV, Petrie MC, Campbell RT. A novel, small-volume subcutaneous furosemide formulation delivered by an abdominal patch infusor device in patients with heart failure: results of two phase I studies. Eur Heart J Cardiovasc Pharmacother. 2024 Jan 5;10(1):35-44. doi: 10.1093/ehjcvp/pvad073.
- Individual participant dataSharing planned: Undecided. to publish
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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.
Mark Petrie, MBChB study chair
University of Glasgow
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 SQIN-01 in people with Heart Failure, run by SQ Innovation, Inc. at 1 site in United Kingdom.
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 4 inclusion and 16 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 24 Apr 2026. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01) (time frame: 0-24 hours after infusion start). The study lists 6 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 NCT04846816, which also lists 1 linked publication.
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 24 Apr 2026.