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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 day 180
Awards & highlights

Study Summary

This trial is testing a new medication for heart failure in adults. The study is double-blind, meaning that neither the participants nor the researchers will know who is receiving the medication or the placebo.

Eligible Conditions
  • Diastolic Heart Failure

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Assessment
Other outcome measures
6-Minute Walking Test (6MWT)
Natriuretic peptide
Quality of Life - Kansas City Cardiomyopathy Questionnaire (KCCQ)
+1 more

Trial Design

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

Find a Location

Who is running the clinical trial?

Salubris Biotherapeutics IncLead Sponsor
2 Previous Clinical Trials
163 Total Patients Enrolled
1 Trials studying Heart Failure
14 Patients Enrolled for Heart Failure
Wilson Tang, MDPrincipal InvestigatorThe Cleveland Clinic
5 Previous Clinical Trials
2,240 Total Patients Enrolled
4 Trials studying Heart Failure
2,190 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.

Is JK07 a risk-free medication for human consumption?

"As this is a Phase 1 trial, there are only preliminary studies which have been conducted to assess JK07's safety; thus our assessment of its risk was rated as low on a scale from 1 to 3."

Answered by AI

Is there an age cutoff for eligibility in this trial?

"This medical trial is specifically looking for participants aged 18 to 85 years old. Subsequent studies will be conducted on those younger than 18 and older than 65, totalling 713 trials in total."

Answered by AI

How widespread is the implementation of this experiment?

"Patients can currently join this clinical trial at 8 different locations, including Rochester, Saint Louis and Stanford. It is important to select the most convenient site for you to minimize travel time if accepted into the study."

Answered by AI

What eligibility criteria must be fulfilled for participation in this trial?

"This clinical trial is seeking 56 participants aged between 18 and 85 with a diagnosis of chronic heart failure. To be eligible, they should display the following characteristics: Stable NYHA class II or III HF symptoms evident for at least half a year, elevated LV end-diastolic pressure/pulmonary capillary wedge pressure (15 mm Hg+ resting; 25 mm HG + exercising), high NT-proBNP & BNP levels (>400 pg/mL & >200 pg/mL respectively), E/e' ratio ≥ 15 on echocardiogram & LAV above 58 mL (males) / 52"

Answered by AI

How many participants are taking part in this medical exploration?

"The trial necessitates 56 volunteers that meet the established criteria. Patients can partake in this study at either Mayo Clinic of Rochester, Minnesota and Washington University in Saint Louis, Missouri."

Answered by AI

Are researchers still accepting new participants for this research project?

"Indeed, the information on clinicaltrials.gov states that this study is currently recruiting for 56 participants from 8 medical sites. The trial originally began recruitment efforts on October 21st 2022 and was most recently updated on November 3rd 2022."

Answered by AI
~0 spots leftby Apr 2025