Trial Outcomes & Findings for A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure (NCT NCT04846816)

Results Overview

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 \[SADEs\]).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

0-24 hours after infusion start

Results posted on

2026-04-24

Participant Flow

This study recruited 20 patients hospitalised with decompensated heart failure recruited from cardiology wards in Queen Elizabeth University Hospital in Glasgow (United Kingdom). Recruitment commenced 6 May 2021 (first subject first visit) and study was completed 13 Aug 2021 (last patient last visit).

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Age, Continuous	72.9 years STANDARD_DEVIATION 11.63 • n=2 Participants
Sex: Female, Male Female	9 Participants n=2 Participants
Sex: Female, Male Male	11 Participants n=2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2 Participants
Race (NIH/OMB) Asian	0 Participants n=2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants
Race (NIH/OMB) Black or African American	0 Participants n=2 Participants
Race (NIH/OMB) White	20 Participants n=2 Participants
Race (NIH/OMB) More than one race	0 Participants n=2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants
Region of Enrollment United Kingdom	20 participants n=2 Participants
Body mass index	30.55 kg/m^2 n=2 Participants

PRIMARY outcome

Timeframe: 0-24 hours after infusion start

Population: All participants

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 \[SADEs\]).

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01) Treatment-Emergent Adverse Events	3 number of events
To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01) Treatment Related Treatment-Emergent Adverse Events	1 number of events

PRIMARY outcome

Timeframe: Baseline, 5 hours after infusion start, 24 hours after infusion start, and maximum pain during 5 hour infusion

Population: All participants

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

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Infusion Site Pain Baseline (pain at the time of device application)	0.5 score on a scale (0 to 10) Interval 0.0 to 4.0
Infusion Site Pain Maximal pain during infusion	0 score on a scale (0 to 10) Interval 0.0 to 5.0
Infusion Site Pain 5 hours after infusion start (pain at the time of device removal)	0 score on a scale (0 to 10) Interval 0.0 to 1.0
Infusion Site Pain Pain 24 hours from the start of infusion	0 score on a scale (0 to 10) Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: During 5 hour infusion

Population: All participants

Any device failures (eg, adhesive failure and drug delivery failure)

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Any Device Failures	1 event

PRIMARY outcome

Timeframe: At baseline

Population: All participants

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

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Plasma Furosemide Concentration	44.07 ng/ml Standard Deviation 39.93

PRIMARY outcome

Timeframe: At 60 minutes

Population: All participants

Plasma furosemide concentration

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Plasma Furosemide Concentration	1291 ng/ml Standard Deviation 615.4

PRIMARY outcome

Timeframe: At 240 minutes

Population: All participants who received full dose of SQIN-Furosemide (one participant excluded due to adhesive failure)

Plasma furosemide concentration

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=19 Participants All participants who were enrolled in the study.
Plasma Furosemide Concentration	2971.1 ng/ml Standard Deviation 1062.83

SECONDARY outcome

Timeframe: 8 hours

Population: All participants

Cumulative urine volume (ml) in urine collected over 8 hours from the start of SQIN-Furosemide infusion

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Urine Volume	1700 ml Interval 620.0 to 4300.0

SECONDARY outcome

Timeframe: 8 hours

Population: All participants

Spot sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Sodium Concentration in Urine	96.5 mmol/l Interval 55.0 to 136.0

SECONDARY outcome

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

Population: All participants

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.)

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Presence of Local Skin Reactions Baseline	0 score on a scale Interval 0.0 to 0.0
Presence of Local Skin Reactions 5 hours post infusion start	0 score on a scale Interval 0.0 to 0.5
Presence of Local Skin Reactions 24 hours pots infusion start	0 score on a scale Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: 5 hours post infusion start

Population: All participants

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.

Outcome measures

Outcome measures
Measure	All Participants (n=20) n=20 Participants All participants who were enrolled in the study.
Patient Acceptability	98.75 score on a scale Interval 45.0 to 100.0

Adverse Events

All Participants (n=20)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants (n=20) n=20 participants at risk All participants who were enrolled in the study.
Musculoskeletal and connective tissue disorders Gout	5.0% 1/20 • Number of events 1 • Through study completion for each participant (beginning at enrollment), around 1 month Details of all adverse events were collected within the eCRF at all follow up visits. The details of each adverse event was collected along with the outcome of the event at the time of the visit i.e. whether the event is ongoing at the time of the visit or the participant has recovered. All Serious Adverse Events (SAEs) were recorded as soon as reasonably practicable and in any event within 24 hours of trial team member first becoming aware of the event.
Cardiac disorders Hypotension	5.0% 1/20 • Number of events 1 • Through study completion for each participant (beginning at enrollment), around 1 month Details of all adverse events were collected within the eCRF at all follow up visits. The details of each adverse event was collected along with the outcome of the event at the time of the visit i.e. whether the event is ongoing at the time of the visit or the participant has recovered. All Serious Adverse Events (SAEs) were recorded as soon as reasonably practicable and in any event within 24 hours of trial team member first becoming aware of the event.
General disorders Fatigue	5.0% 1/20 • Number of events 1 • Through study completion for each participant (beginning at enrollment), around 1 month Details of all adverse events were collected within the eCRF at all follow up visits. The details of each adverse event was collected along with the outcome of the event at the time of the visit i.e. whether the event is ongoing at the time of the visit or the participant has recovered. All Serious Adverse Events (SAEs) were recorded as soon as reasonably practicable and in any event within 24 hours of trial team member first becoming aware of the event.

Additional Information

Professor Mark Petrie

University of Glasgow

Phone: 0044 141 330 2267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place