A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure (SUBCUT-HF I)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Combination product: SQIN-01

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SQIN-01; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SQ Innovation, Inc.
• Collaborators: NHS Greater Glasgow and Clyde; University of Glasgow
• Investigators: Study Chair: Mark Petrie, MBChB, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: GN18CA193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: to publish

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No