Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00448253 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
NCT00448253: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT00448253 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 92 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00448253, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.
Interventions
- BIOLOGICAL NP-015
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
What the finished NCT00448253 record still lists
NCT00448253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 1 intervention - of which NP-015 is the first listed.
NCT00448253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00448253 about?
NCT00448253 is a clinical study titled "Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum". The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-01...
What is the current status of trial NCT00448253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2007-07. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00448253?
The interventions under investigation include: NP-015 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00448253?
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 NCT00448253's enrollment target sits among peer trials
92 625th of 2000 higher than 1,375 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03184545 · 92 participants · Phase 3
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
- NCT04172532 · 92 participants · Phase 1
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
- NCT04508088 · 92 participants
Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease
- NCT04840602 · 92 participants · Phase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia