Clinical trial
Pharmacokinetic (PK) and Safety Study of Plasma-derived Human…
NCT00333515 · Baxalta now part of Shire, Industry · Completed
Key facts
| NCT number | NCT00333515 |
|---|---|
| Title | Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously |
| Official title | A Phase 1, Randomized, Observer-blinded, Single Dose, Placebo Controlled Dosage-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Plasma-Derived Human Butyrylcholinesterase (HuBChE) Administered Intravenously (IV) |
| Lead sponsor | Baxalta now part of Shire, Industry |
| Collaborators | DynPort Vaccine Company LLC, A GDIT Company Industry |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Healthy Volunteers, Chemical Terrorism, Chemical Warfare |
| Intervention type | Drug |
| Interventions | Human Butyrylcholinesterase (HuBChE) derived from human plasma, Placebo: Normal saline |
| Enrollment | 28 |
| Start date | Jan 1, 2007 |
| Primary completion | Apr 1, 2008 |
| Completion | Aug 1, 2008 |
| First posted | Jun 5, 2006 |
| Last update posted | May 5, 2021 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: