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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 is a Phase 1 study that has completed, run by Salubris Biotherapeutics. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04210375
The ClinicalTrials.gov registry entry for NCT04210375 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Salubris Biotherapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04210375 reports 0 study locations.
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.
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