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NCT04210375 · ClinicalTrials.gov registry record · Phase 1
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
A Phase 1 study, sponsored by Salubris Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04210375: Completed Phase 1 study, sponsored by Salubris Biotherapeutics.
NCT04210375 is a Phase 1 study that has completed, run by Salubris Biotherapeutics. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04210375, a Phase 1 study, has completed, sponsored by Salubris Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study to assess the safety, tolerability, immunogenicity, PK, and exploratory efficacy of JK07 in subjects 18 to 80 years of age with HFrEF ≤40%. Initially 5 cohorts are planned with the option to expand the study to a total of 7 cohorts. The size of the cohorts will range from 5 to 9 subjects. Each cohort will include one single active unblinded sentinel subject receiving a single IV dose of JK07 prior to randomized single dose administration of JK07 or placebo \[3:1\] in the remainder of the cohort.
Primary Outcome
All safety information is collected and evaluated.
Interventions
- DRUG Matching Placebo
- DRUG JK07
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2023-07-07 |
| Phase | Phase 1 |
What the finished NCT04210375 record still lists
NCT04210375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04210375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04210375 about?
NCT04210375 is a clinical study titled "Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)". This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study to assess the safety, tolerability, immunogenicity, PK, and exploratory efficacy of JK07 in subjects 18 to 80 years of age with HFrEF ≤40%. Initially 5 cohorts are planned with the option to expand the stud...
What is the current status of trial NCT04210375?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-09-21. Estimated completion is 2023-07-07.
What interventions are being tested in trial NCT04210375?
The interventions under investigation include: Matching Placebo (DRUG), JK07 (DRUG).
Who is sponsoring clinical trial NCT04210375?
This trial is sponsored by Salubris Biotherapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04210375's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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