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

NCT04846816 | Completed Phase 1 Results DMC

• 1 other identifier: GN18CA193
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (6)

• 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 \[SADEs\]).

  0-24 hours after infusion start

• Infusion Site Pain

  Measured on a scale of 0 = no pain to 10 = maximal pain

  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)

  During 5 hour infusion

• Plasma Furosemide Concentration

  Plasma furosemide concentration (at 0 min, pre-treatment)

  At baseline

• Plasma Furosemide Concentration

  Plasma furosemide concentration

  At 60 minutes

• Plasma Furosemide Concentration

  Plasma furosemide concentration

  At 240 minutes

Secondary Outcomes (4)

• Urine Volume

  8 hours

• Sodium Concentration in Urine

  8 hours

• Presence of Local Skin Reactions

  Baseline, 5 hours post infusion start, and 24 hours post infusion start

• Patient Acceptability

  5 hours post infusion start

Study Arms (1)

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.

Combination Product: SQIN-01

Interventions

SQIN-01 COMBINATION_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.

SQIN-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SQ Innovation, Inc.: lead
• University of Glasgow: collaborator
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

Glasgow, Glasgow, G51 4TF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37804170 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Professor Mark Petrie
• Organization: University of Glasgow

mark.petrie@glasgow.ac.uk

0044 141 330 2267

Study Officials

• Mark Petrie, MBChB

  University of Glasgow

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: May 6, 2021
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2024-10

Locations

GB (1)