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NCT01236404 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Study to Assess Safety, Tolerability, PK and PD Response of PB1023 Injection Following Single and Multiple SQ Doses in Adults With Type 2 Diabetes Mellitus
A Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01236404 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 80 participants.
The verdict
NCT01236404, a Phase 1 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
Primary objective: To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM. Secondary objectives: 1. To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023. 2. To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid Mixed Meal Tolerance Test (MMTT).
Interventions
- DRUG Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)
- DRUG Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01236404
The ClinicalTrials.gov registry entry for NCT01236404 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 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 2 interventions - of which Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl) is the first listed.
NCT01236404 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01236404 about?
NCT01236404 is a clinical study titled "Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Study to Assess Safety, Tolerability, PK and PD Response of PB1023 Injection Following Single and Multiple SQ Doses in Adults With Type 2 Diabetes Mellitus". Primary objective: To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM. Secondary objectives: 1. To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending...
What is the current status of trial NCT01236404?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2010-11. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01236404?
The interventions under investigation include: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl) (DRUG), Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl) (DRUG).
Who is sponsoring clinical trial NCT01236404?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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