A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Combination Product: SQIN-01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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 Exclusion Criteria: • 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SQIN-01<br>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. | Combination Product: SQIN-01<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and adverse drug events | 24 hours from start of infusion | 
| Infusion site pain | Measured on a scale of 0 = no pain to 10 = most pain | During 5 hour infusion | 
| Any device failures | Any device failures | During 5 hour infusion | 
| Serum furosemide concentration | Serum furosemide concentration | At baseline | 
| Serum furosemide concentration | Serum furosemide concentration | At 60 minutes | 
| Serum furosemide concentration | Serum furosemide concentration | At 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine volume | Urine volume (ml) in urine collected 8 hours after start of SQIN-Furosemide infusion | 8 hours | 
| Sodium concentration in urine | Sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion | 8 hours | 
| Presence of local skin reactions | Presence of local skin reactions on examination | After 5 hour infusion | 
| 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. | After 5 hour infusion |