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NCT02724085 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271
A Phase 1 study of Pneumonia, sponsored by Tetraphase Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT02724085: Completed Phase 1 study of Pneumonia, sponsored by Tetraphase Pharmaceuticals.
NCT02724085 is a Phase 1 study of Pneumonia that has completed, run by Tetraphase Pharmaceuticals. The registered enrollment target is 57 participants, below the 4,518-participant average among 47 other Pneumonia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02724085, a Phase 1 study of Pneumonia, has completed, sponsored by Tetraphase Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Primary Outcome
The incidence, intensity, and type of adverse events (AE) Outcome measures to be collected in support of the primary objective (safety and tolerability) include: * The incidence, intensity, and type of AEs (from time of signing of informed consent form \[ICF\] through EOS); * Changes in physical examination findings (Day -1 and EOS); * Changes in vital signs (Day -1 through EOS); * Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results (Days -1 through EOS); and
Conditions Studied
Interventions
- DRUG TP-271
Study Locations (1)
Texas
- PPD Phase 1 Clinic - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2015-12-18 |
| Est. Completion | 2016-12-12 |
| Phase | Phase 1 |
What the finished NCT02724085 record still lists
NCT02724085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 4,518-participant average among 47 other Pneumonia trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Pneumonia appearing as the primary indexed condition, and to 1 intervention - of which TP-271 is the first listed.
NCT02724085 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02724085 about?
NCT02724085 is a clinical study titled "A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271". This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this stu...
What is the current status of trial NCT02724085?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2015-12-18. Estimated completion is 2016-12-12.
What conditions does trial NCT02724085 study?
This clinical trial studies the following conditions: Pneumonia.
What interventions are being tested in trial NCT02724085?
The interventions under investigation include: TP-271 (DRUG).
Who is sponsoring clinical trial NCT02724085?
This trial is sponsored by Tetraphase Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02724085 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02724085's enrollment target sits among peer trials
57 34th of 47 higher than 14 of 47 other Pneumonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pneumonia 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.
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