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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: Completed Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
NCT01236404 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented.
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 |
What the finished NCT01236404 record still lists
NCT01236404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01236404's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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