Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 16 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DRUG PB1023 Injection

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2011-12
Est. Completion 2012-10
Phase Phase 1

Sponsor

PhaseBio Pharmaceuticals

13 total trials

What the Registry Record Tells You About NCT01478399

The ClinicalTrials.gov registry entry for NCT01478399 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PhaseBio Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which PB1023 Injection is the first listed.

NCT01478399 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.