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NCT05711381 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function
A Phase 1 study of Renal Impairment, sponsored by Hanmi Pharmaceutical Company Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 4
- Study locations
NCT05711381: Completed Phase 1 study of Renal Impairment, sponsored by Hanmi Pharmaceutical Company Limited.
NCT05711381 is a Phase 1 study of Renal Impairment that has completed, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 16 participants, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (53% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05711381, a Phase 1 study of Renal Impairment, has completed, sponsored by Hanmi Pharmaceutical Company Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 4
- Study locations
Study Summary
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
Primary Outcome
Pharmacokinetic (PK) samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.
Conditions Studied
Interventions
- DRUG HM15912
Study Locations (4)
Florida
- Clinical Pharmacology of Miami - Miami
- Panax Clinical Research - Miami Lakes
California
- Orange County Research Center - Tustin
Tennessee
- AMR Knoxville - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-12-02 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 1 |
What the finished NCT05711381 record still lists
NCT05711381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which HM15912 is the first listed.
NCT05711381 reports a single indexed study location in Florida, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05711381 about?
NCT05711381 is a clinical study titled "Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function". An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
What is the current status of trial NCT05711381?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-12-02. Estimated completion is 2023-08-15.
What conditions does trial NCT05711381 study?
This clinical trial studies the following conditions: Renal Impairment.
What interventions are being tested in trial NCT05711381?
The interventions under investigation include: HM15912 (DRUG).
Who is sponsoring clinical trial NCT05711381?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05711381 being conducted?
This trial has 4 study locations across California, Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05711381's enrollment target sits among peer trials
16 28th of 32 higher than 2 of 32 other Renal Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Impairment 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.
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