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NCT02653014 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment
A Phase 1 study, sponsored by KBP Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT02653014: Completed Phase 1 study, sponsored by KBP Biosciences.
NCT02653014 is a Phase 1 study that has completed, run by KBP Biosciences. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02653014, a Phase 1 study, has completed, sponsored by KBP Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III study.
Primary Outcome
Rate of adverse events
Interventions
- DRUG KBP-5074
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-07-29 |
| Est. Completion | 2017-03-28 |
| Phase | Phase 1 |
What the finished NCT02653014 record still lists
NCT02653014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which KBP-5074 is the first listed.
NCT02653014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02653014 about?
NCT02653014 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment". This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma aldosterone, serum potassium, UAC...
What is the current status of trial NCT02653014?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2015-07-29. Estimated completion is 2017-03-28.
What interventions are being tested in trial NCT02653014?
The interventions under investigation include: KBP-5074 (DRUG).
Who is sponsoring clinical trial NCT02653014?
This trial is sponsored by KBP Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02653014's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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