Study to Compare Bioavailability and Pharmacokinetics of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Healthy Volunteers (SQI-01-03)

An Open-label, Single-dose, Randomized, Two-way, Two-period Crossover Study to Compare Bioavailability and Pharmacokinetics of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Healthy Volunteers

The trial is to compare the bioavailability of the original European Lasix (furosemide injection) administered in accordance with its prescribing information with the same dose of a novel furosemide formulation developed for this subcutaneous administration. The study will also investigate PK and PD of these regimens.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: SQIN-Furosemide; Drug: Lasix ® Infusion

Detailed Description

This study will be an open-label, single-dose, randomized, two-way, two-period crossover study in 15 healthy adult volunteers.

Each participant will complete Screening, two Treatment phases, and Follow-up. The Screening Phase will be conducted on an outpatient basis up to 28 days prior to dosing. The Treatment Phase will comprise 2 crossover treatment periods separated by a minimum 7-day outpatient fluid re-equilibration and washout.

Participants will be admitted to the CRU on Day 1, and final eligibility assessments will be completed. Participants will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences (AB or BA) to receive subcutaneous furosemide (Treatment A; Test) and IV furosemide (Treatment B; Reference). Participants randomized to sequence AB will receive subcutaneous furosemide for Treatment Period 1 and IV furosemide for Treatment Period 2, with treatments administered vice versa for sequence BA.

Study treatment based on the participant's assigned treatment sequence will be administered beginning in the morning of Day 1. SQIN-Furosemide will be administered by the BD Alaris™ neXus CC Syringe Pump and an infusion set programmed to delivers 30mg over first 60 minutes (total 1mL), followed by 50mg over 4 hours (total ~1.7mL), for a total dose and volume administered over 5 hours of 80mg and ~2.7mL, respectively. Furosemide Injection (20 mg/2mL) will be administered IV also with the use of the BD Alaris™ neXus CC Syringe Pump. Two doses of 40mg each will be infused at a rate of 4mg/min, such that the total amount of furosemide administered is 80 mg. PK, PD, and safety assessments will be collected over 24 hours, as detailed in the Schedule of Assessments. Participants will repeat the same procedures for Treatment Period 2 as for Treatment Period 1.

Participants will remain domiciled in the CRU through 24 hours after administration of study drug. Participants will be discharged from the CRU after all Day 2 study procedures and assessments have been completed, provided that safety parameters are acceptable to the Investigator. After the conclusion of Treatment 1 and prior to discharge, participants will be instructed regarding the diet and fluid intake, what to watch out for, how to contact study staff and when to return for Period 2. Participants will repeat the same procedures for Treatment Period 2 as for Treatment Period 1, this time receiving the alternative (cross-over) treatment.

Participants will be admitted to the CRU on the day of dosing in Treatment Period 2 and eligibility will be reconfirmed. subcutaneous or IV furosemide will then be administered on Day 9, according to the participant's randomization sequence, with PK, PD, and safety assessments collected over 24 hours, as detailed in the Schedule of Assessments.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G4 0SF
      • BDD Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Written informed consent
• Male or female ≥18 years of age
• BMI between 18.5 and 32.0 kg/m2 (inclusive)
• Females will be non-pregnant and non-lactating
• Able to participate in the study in the opinion of the Investigator
• Has the ability to understand the requirements of the study and is willing to comply with all study procedures

Exclusion Criteria:

• Unable to consent to inclusion in study
• eGFR < 60 mL/min/1.73 m2
• Use of diuretics
• Systolic blood pressure (SBP) <90 mmHg
• Potassium < 3.5 or > 5.3 mmol/L
• Sodium < 133 or > 146 mmol/L
• Comorbidities or health issues which in the opinion of the investigator may interfere with study participation or study assessments.
• Major surgery within 30 days prior to Screening.
• Administration of an investigational drug or implantation of investigational device, or participation in another interventional trial, within 30 days prior to Screening, or 5 half-lives, whichever is longer.
• Pregnancy or breastfeeding
• 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 participant, interfere with participation in the study or which may affect the integrity of the data
• Any clinically significant findings in Screening laboratory results which in the opinion of the investigator may pose an undue risk to the participant, 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: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SQIN-Furosemide is an investigational subcutaneous furosemide formulation at 30mg/mL; In this study 80mg of SQIN-Furosemide will be administered subcutaneously over 5 hours using biphasic delivery profile of 30mg in the first hour and 50mg over the remaining 4 hours. IMP will be delivered by BD Alaris™ neXus CC Syringe Pump.	Drug: SQIN-Furosemide; SQIN-Furosemide is a novel formulation of furosemide at 30mg/mL at pH 7.5 (range 7.1 to 7.8) intended for subcutaneous use.; Other Names: Lasix ONYU
Active Comparator: Sanofi Aventis 20mg/2mL Lasix infusion; 80mg IV bolus administered over 2 doses of 40mg each for 10 mins, 2 hours apart (4mg/min).	Drug: Lasix ® Infusion; Sanofi Aventis 20mg/2mL Lasix infusion. 80mg IV bolus administered over 2 doses of 40mg each for 10 mins, 2 hours apart (4mg/min).; Other Names: Sanofi Aventis 20mg/2mL Lasix infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute bioavailability	Absolute bioavailability following 5-hour subcutaneous infusion based on a comparison of AUC (subcutaneous:IV) of furosemide.	From enrollment to end of treatment, 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters - Cmax	Maximum plasma concentration (Cmax) over the timeframe of 24 hours	From beginning of treatment to 24 hours post-treatment
Urine volume	Urine volume in liters	From beginning of treatment to 24 hours post-dose
Pharmacokinetic measures - Tmax	Time to Cmax (Tmax) over 24 hours	From beginning to 24 hours post-dose
Pharmacokinetic measures - AUC	Area under the concentration versus time curve (AUC) from time 0 to the last measurable plasma concentration (AUClast) and to infinity (AUCinf), half-life (t½), apparent systemic clearance and volume of distribution (subcutaneous only), and systemic clearance and volume of distribution (IV only)	From beginning of treatment to 24 hours post-dose
Sodium concentration in urine	Sodium concentration in urine in mmols	From beginning of treatment to 24 hours post-dose

Collaborators and Investigators

• Sponsor: SQ Innovation, Inc.
• Collaborators: BDD Pharma Ltd
• Investigators: Principal Investigator: Lyn Cory, MD, BDD Pharma Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Actual): March 9, 2026
• Study Completion (Actual): March 9, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SQI-01-03; 1013098 (Other Identifier: IRAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes