NCT04846816

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: SQ Innovation, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-06
• Primary completion: 2021-08-13
• Completion: 2021-08-13
• First posted: 2021-04-15
• Last updated: 2021-11-26

Locations

1 site across 1 country: United Kingdom