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NCT01202695 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01202695 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 50 participants.
The verdict
NCT01202695, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Primary: • To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: * To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 * To evaluate the immunogenicity of AVP-21D9
Interventions
- DRUG Placebo
- DRUG AVP-21D9
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01202695
The ClinicalTrials.gov registry entry for NCT01202695 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01202695 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01202695 about?
NCT01202695 is a clinical study titled "Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)". Primary: • To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: * To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 * To evaluate the immunogenicity of AVP-21D9
What is the current status of trial NCT01202695?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2010-08. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01202695?
The interventions under investigation include: Placebo (DRUG), AVP-21D9 (DRUG).
Who is sponsoring clinical trial NCT01202695?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
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