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NCT01427257 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus
A Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01427257 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 10 participants.
The verdict
NCT01427257, a Phase 1 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Primary objective: To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations). Secondary objectives: To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous injection in adult subjects with T2DM. To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.
Interventions
- DRUG Single Dose PB1023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01427257
The ClinicalTrials.gov registry entry for NCT01427257 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 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 Single Dose PB1023 is the first listed.
NCT01427257 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01427257 about?
NCT01427257 is a clinical study titled "Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus". Primary objective: To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations). Secondary objectives: To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous...
What is the current status of trial NCT01427257?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-02. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01427257?
The interventions under investigation include: Single Dose PB1023 (DRUG).
Who is sponsoring clinical trial NCT01427257?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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