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

NCT07269496 | Completed Phase 1 FDA Drug

• 2 other identifiers: SQI-01-031013098
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pharmacokinetic parameters - Cmax

  From beginning of treatment to 24 hours post-treatment

• Urine volume

  From beginning of treatment to 24 hours post-dose

• Pharmacokinetic measures - Tmax

  From beginning to 24 hours post-dose

• Pharmacokinetic measures - AUC

  From beginning of treatment to 24 hours post-dose

• Sodium concentration in urine

  From beginning of treatment to 24 hours post-dose

Study Arms (2)

SQIN-Furosemide is an investigational subcutaneous furosemide formulation at 30mg/mL

EXPERIMENTAL

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

Sanofi Aventis 20mg/2mL Lasix infusion

ACTIVE COMPARATOR

80mg IV bolus administered over 2 doses of 40mg each for 10 mins, 2 hours apart (4mg/min).

Drug: Lasix ® Infusion

Interventions

SQIN-Furosemide DRUG

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.

Also known as: Lasix ONYU

SQIN-Furosemide is an investigational subcutaneous furosemide formulation at 30mg/mL

Lasix ® Infusion DRUG

Sanofi Aventis 20mg/2mL Lasix infusion. 80mg IV bolus administered over 2 doses of 40mg each for 10 mins, 2 hours apart (4mg/min).

Also known as: Sanofi Aventis 20mg/2mL Lasix infusion

Sanofi Aventis 20mg/2mL Lasix infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SQ Innovation, Inc.: lead
• BDD Pharma Ltd: collaborator

Study Sites (1)

BDD Pharma

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Study Officials

• Lyn Cory, MD

  BDD Pharma Ltd

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This study will be an open-label, single-dose, randomized, two-way, two-period crossover study

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 8, 2025
• Study Start: February 9, 2026
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-11

Locations

GB (1)