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JK07 for Heart Failure

Phase 1
Waitlist Available
Led By Wilson Tang, MD
Research Sponsored by Salubris Biotherapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to 180 days
Awards & highlights

Study Summary

This trial is testing a new drug to treat heart failure. The drug will be given to a small group of people to see if it is safe and effective. The group will be given either the new drug or a placebo, and the study will see if the new drug works better than the placebo.

Eligible Conditions
  • Heart Failure with Reduced Ejection Fraction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of treatment-emergent adverse events [safety and tolerability]
Secondary outcome measures
Pharmacokinetics (area under the concentration versus time curve) of JK07
Other outcome measures
Biomarkers
Concentration-QT correlation
Left ventricular and systemic vascular resistance assessment

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: JK07Active Control1 Intervention
Single dose of JK07 administered by intravenous infusion over 60 minutes
Group II: Matching PlaceboPlacebo Group1 Intervention
Single dose of placebo administered by intravenous infusion over 60 minutes

Find a Location

Who is running the clinical trial?

Salubris Biotherapeutics IncLead Sponsor
3 Previous Clinical Trials
545 Total Patients Enrolled
2 Trials studying Heart Failure
282 Patients Enrolled for Heart Failure
Wilson Tang, MDPrincipal InvestigatorThe Cleveland Clinic
5 Previous Clinical Trials
2,226 Total Patients Enrolled
4 Trials studying Heart Failure
2,176 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration officially accepted JK07 for clinical use?

"JK07 has yet to be clinically evaluated in depth, so it recieved a score of 1."

Answered by AI

How many participants are being recruited for this trial?

"Salubris Biotherapeutics Inc has determined that 63 individuals fulfilling the requirements for this trial are required to complete its successful execution. The research will be conducted across two sites, Hospital of the University of Pennsylvania in Philadelphia and Stanford University Medical Center in California."

Answered by AI

Who would be most suitable to take part in this medical experiment?

"Aspiring participants must have been diagnosed with heart failure and be between 18-80 years old to join this medical trial. Currently, 63 patients are being sought out for enrollment in the study."

Answered by AI

Are there any facilities administering this research in the North American region?

"At this time, 9 medical centres have been authorised to recruit participants for the trial. This includes facilities in Philadelphia, Stanford and Boston among other cities. To minimise travel expenses associated with participation, selecting a centre closest to you is advisable."

Answered by AI

Does this experiment accept participants older than seventy years of age?

"The enrollment requirements for this clinical trial stipulate that participants must be at least 18 years of age, but not exceed 80."

Answered by AI

Are there still open slots available for participants in this trial?

"As noted on clinicaltrials.gov, this trial is searching for volunteers to take part in the study. It was initiated on September 21st 2020 and last updated November 3rd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Oregon Health Science University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've been living with heart failure for about 7 years now. My medication doesn't seem to be working anymore.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
2020. "Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210375.
~3 spots leftby Apr 2025
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