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NCT01357213 · ClinicalTrials.gov registry record · Phase 1
Phase 1 PK Study of XOMA 3AB
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01357213 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants.
The verdict
NCT01357213, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the 24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in which they will receive a single intravenous infusion of active drug or placebo. Placebo will be normal saline. Volunteers will be followed for safety for up to 120 days after infusion depending on dose cohort.
Interventions
- OTHER Placebo
- DRUG XOMA 3AB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01357213
The ClinicalTrials.gov registry entry for NCT01357213 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01357213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01357213 about?
NCT01357213 is a clinical study titled "Phase 1 PK Study of XOMA 3AB". This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the 24-hour blood draw. Three e...
What is the current status of trial NCT01357213?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-05. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01357213?
The interventions under investigation include: Placebo (OTHER), XOMA 3AB (DRUG).
Who is sponsoring clinical trial NCT01357213?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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