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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: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT01202695 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 90 or the early withdrawl visit, if applicable.
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 |
What the finished NCT01202695 record still lists
NCT01202695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01202695 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01202695's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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