Heart FailurePhase 1NCT06167707
Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers
A Phase 1 study testing SCP-111 and Furosemide USP in people with Heart Failure and Fluid Overload, run by scPharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study aims to compare the pharmacokinetics and pharmacodynamics of subcutaneous (SC) and intravenous (IV) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Fluid Overload
- What is being tested?
- SCP-111 and Furosemide USP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2024to 14 Jun 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects 45 to 80 years of age.
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
- In the opinion of the Investigator, able to participate in the study.
Who cannot join
- Pregnant or lactating women or women of childbearing age who are not willing to use an adequate form of contraception.
- Systolic BP (SBP) < 90 mmHg at screening or baseline.
- Heart rate > 110 beats per minute (BPM) at screening or baseline.
- Temperature > 38°C (oral or equivalent).
- Serum potassium < 3.0 or > 5.5 mEq/L at screening.
- Other significant cardiac abnormalities which may interfere with study participation or study assessments.
Show all 20Show fewer
- Current or planned treatment during the study with any IV therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues. scPharmaceuticals, Inc. SCP-111 PK/PD Study Protocol Number: scP-04-001 Confidential Page 14 of 56
- Presence of implanted ventricular assist device, cardiac defibrillator or pacemaker.
- Severely impaired renal function, defined as an estimated glomerular filtration rate (eGFR) at screening admission < 30 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation.
- Urinary retention due to bladder emptying disorders and/or urethral narrowing.
- Presence or need for urinary catheterization.
- Reported history of hepatic cirrhosis.
- Administration of intravenous radiographic contrast agent within 72 hours prior to Screening.
- Concomitant or any use within past 30 days of drugs known to interact with furosemide (aminoglycoside antibiotics, ethacrynic acid, high doses of salicylates, cisplatin, tubocurarine, succinylcholine, chloral hydrate, phenytoin, methotrexate, indomethacin, or lithium).
- Administration of an investigational drug or implantation of investigational device, or participation in another interventional clinical trial, within 30 days prior to Screening.
- Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study.
- Positive urine drug screen at Screening or Baseline.
- Blood alcohol concentration > 2 mg/dL (0.02%) at Screening.
- Alcohol breath test > 2 mg/dL (0.02%) on admission to the CRU.
- History of severe allergic or hypersensitivity reactions to furosemide or any component of the SCP-111 formulation (tromethamine or benzyl alcohol)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single-dose, Randomized, Two-way Crossover Study to Compare the Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of SCP-111 (Furosemide) vs Intravenous Injection of Furosemide in Healthy Volunteers
This study aims to compare the pharmacokinetics and pharmacodynamics of subcutaneous (SC) and intravenous (IV) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. A commercial formulation of furosemide injection, USP, solution 10 mg/mL administered as a 40 mg IV injection over 2 minutes followed by a second dose of 40 mg, 2 hours later, will serve as the reference drug.
The objectives of this study are:
- To estimate the bioavailability and describe the pharmacokinetics and pharmacodynamics of furosemide administered as SC injection via autoinjector compared with equivalent dose of furosemide administered as two 40 mg IV injections, two hours apart.
- To describe the safety and tolerability of furosemide administered as SC injection via an autoinjector.
Read the detailed description
This is an open-label, single-center, single-dose, randomized, two-way crossover study in healthy volunteers. Each Subject will complete Screening, Baseline, Treatment, and Follow-up Phases.
After a Screening Phase, Subjects meeting entry criteria will be admitted to the clinical research unit (CRU) and undergo baseline assessments. Subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences (IV furosemide followed by SC or vice versa). Subjects will remain domiciled in the CRU for each treatment period which will be about 12-hours. After final assessments are performed, Subjects may be discharged from the CRU if safety parameters are acceptable to the Investigator and return to the CRU after a 3-day washout period to receive the second treatment sequence. The Follow-up Phase will occur 24-48 hours after discharge from the CRU following treatment sequence 2, completing Subjects' study participation.
- Conditions
- Heart Failure, Fluid Overload
- Being tested
- SCP-111, Furosemide USP
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCP-111Drug
Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USPDrug
Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Period 1: SC Period 2: IV Receives: Drug: SCP-111; Drug: Furosemide USP |
| Treatment Sequence 2 | Experimental | Period 1: IV Period 2: SC Receives: Drug: SCP-111; Drug: Furosemide USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. IV:
AUCinf
Area under the plasma concentration-time curve from time 0 (pre-dose) extrapolated to infinity.
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
AUCext
The percentage of the AUC that is extrapolated beyond the last measurable concentration.
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Cmax
Maximum observed plasma concentration of Furosemide
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Tmax
Time of maximum observed Furosemide plasma concentration
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
λz
Apparent plasma terminal-phase elimination rate constant
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
t½
Terminal-phase half-life
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Clearance
Systemic clearance for IV furosemide (CL) and Apparent systemic clearance for SC furosemide (CL/F)
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Volume of Distribution, Terminal Phase
Systemic Volume of distribution, terminal phase for IV furosemide (V) and Apparent Volume of distribution, terminal phase for SC furosemide (Vz/F)
Measured: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Urine Output 0-6 Hours
Total Urine Output from 0 to 6 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose
Urine Output 0-8 Hours
Total Urine Output from 0 to 8 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose
Urine Output 0-12 Hours
Total Urine Output from 0 to 12 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose
Urinary Sodium 0-6 Hours
Urinary sodium excretion from 0 to 6 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose
Urinary Sodium 0-8 Hours
Urinary sodium excretion from 0 to 8 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose
Urinary Sodium 0-12 Hours
Urinary sodium excretion from 0 to 12 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose
Urinary Potassium 0-6 Hours
Urinary potassium excretion from 0 to 6 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose
Urinary Potassium 0-8 Hours
Urinary potassium excretion from 0 to 8 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose
Urinary Potassium 0-12 Hours
Urinary potassium excretion from 0 to 12 hours
Measured: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose
Secondary outcomes (1)
Injection Site Pain
Injection site pain was assessed using an 11-point scale where 0 was equivalent to no pain and 10 was equivalent to the worst possible pain.
Measured: SC SCP-111: pre-dose, immediately after dose, 15, 30 minutes and 6,12 hours post-dose. IV Furosemide: pre-dose, after place IV needle, immediately after 1st IV dose; 15, 30, minutes, immediately after 2nd dose,15, 30 minutes and 4, 10 hours after 2nd dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start19 Apr 2024
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- scPharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167707
- Sponsor's protocol ID
- scP-04-001
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2023
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-dose, Randomized, Two-way Crossover Study to Compare the Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of SCP-111 (Furosemide) vs Intravenous Injection of Furosemide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06167707
- Acronym / sponsor ID
- scP-04-001
- Conditions
- Heart Failure, Fluid Overload
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- scPharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the pharmacokinetics and pharmacodynamics of subcutaneous (SC) and intravenous (IV) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. A commercial formulation of furosemide injection, USP, solution 10 mg/mL administered as a 40 mg IV injection over 2 minutes followed by a second dose of 40 mg, 2 hours later, will serve as the reference drug.
The objectives of this study are:
- To estimate the bioavailability and describe the pharmacokinetics and pharmacodynamics of furosemide administered as SC injection via autoinjector compared with equivalent dose of furosemide administered as two 40 mg IV injections, two hours apart.
- To describe the safety and tolerability of furosemide administered as SC injection via an autoinjector.
Detailed description
This is an open-label, single-center, single-dose, randomized, two-way crossover study in healthy volunteers. Each Subject will complete Screening, Baseline, Treatment, and Follow-up Phases.
After a Screening Phase, Subjects meeting entry criteria will be admitted to the clinical research unit (CRU) and undergo baseline assessments. Subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences (IV furosemide followed by SC or vice versa). Subjects will remain domiciled in the CRU for each treatment period which will be about 12-hours. After final assessments are performed, Subjects may be discharged from the CRU if safety parameters are acceptable to the Investigator and return to the CRU after a 3-day washout period to receive the second treatment sequence. The Follow-up Phase will occur 24-48 hours after discharge from the CRU following treatment sequence 2, completing Subjects' study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: SCP-111, Drug: Furosemide USPPeriod 1: SC Period 2: IV |
| Treatment Sequence 2 | Experimental | Drug: SCP-111, Drug: Furosemide USPPeriod 1: IV Period 2: SC |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects 45 to 80 years of age.
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
- In the opinion of the Investigator, able to participate in the study.
Key exclusion criteria (20 listed)
- Pregnant or lactating women or women of childbearing age who are not willing to use an adequate form of contraception.
- Systolic BP (SBP) < 90 mmHg at screening or baseline.
- Heart rate > 110 beats per minute (BPM) at screening or baseline.
- Temperature > 38°C (oral or equivalent).
- Serum potassium < 3.0 or > 5.5 mEq/L at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCP-111Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose | Drug | Treatment Sequence 1, Treatment Sequence 2 |
| Furosemide USPFurosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later | Drug | Treatment Sequence 1, Treatment Sequence 2 |
Primary outcome
AUClast
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. IV:
Area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
AUCinf
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Area under the plasma concentration-time curve from time 0 (pre-dose) extrapolated to infinity.
AUCext
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
The percentage of the AUC that is extrapolated beyond the last measurable concentration.
Cmax
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Maximum observed plasma concentration of Furosemide
Tmax
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Time of maximum observed Furosemide plasma concentration
λz
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Apparent plasma terminal-phase elimination rate constant
t½
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Terminal-phase half-life
Clearance
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Systemic clearance for IV furosemide (CL) and Apparent systemic clearance for SC furosemide (CL/F)
Volume of Distribution, Terminal Phase
Time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Systemic Volume of distribution, terminal phase for IV furosemide (V) and Apparent Volume of distribution, terminal phase for SC furosemide (Vz/F)
Urine Output 0-6 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose
Total Urine Output from 0 to 6 hours
Urine Output 0-8 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose
Total Urine Output from 0 to 8 hours
Urine Output 0-12 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose
Total Urine Output from 0 to 12 hours
Urinary Sodium 0-6 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose
Urinary sodium excretion from 0 to 6 hours
Urinary Sodium 0-8 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose
Urinary sodium excretion from 0 to 8 hours
Urinary Sodium 0-12 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose
Urinary sodium excretion from 0 to 12 hours
Urinary Potassium 0-6 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose
Urinary potassium excretion from 0 to 6 hours
Urinary Potassium 0-8 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose
Urinary potassium excretion from 0 to 8 hours
Urinary Potassium 0-12 Hours
Time frame: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose
Urinary potassium excretion from 0 to 12 hours
1 secondary outcome
Injection Site Pain
Time frame: SC SCP-111: pre-dose, immediately after dose, 15, 30 minutes and 6,12 hours post-dose. IV Furosemide: pre-dose, after place IV needle, immediately after 1st IV dose; 15, 30, minutes, immediately after 2nd dose,15, 30 minutes and 4, 10 hours after 2nd dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCP-111 and Furosemide USP in people with Heart Failure and Fluid Overload, run by scPharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUClast (time frame: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. IV:). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.