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NCT01478399 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
A Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01478399: Completed Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
NCT01478399 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478399, a Phase 1 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function. Secondary objectives: To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.
Primary Outcome
The PK analysis population will consist of subjects that complete the study and have sufficient data for PK analysis. The following parameters will be evaluated: t1/2, AUC(0-inf), Tmax, Cmax, elimination rate constant, CL/F, Vz/F.
Interventions
- DRUG PB1023 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT01478399 record still lists
NCT01478399 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which PB1023 Injection is the first listed.
NCT01478399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01478399 about?
NCT01478399 is a clinical study titled "Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function". Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function. Secondary objectives: To evaluate the safety and tolerability of Glymera (PB1023) ...
What is the current status of trial NCT01478399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2011-12. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01478399?
The interventions under investigation include: PB1023 Injection (DRUG).
Who is sponsoring clinical trial NCT01478399?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01478399's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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