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NCT00333515
Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously
Phase 1 trial testing Human Butyrylcholinesterase (HuBChE) derived from human plasma in Healthy Volunteers in 28 participants. Completed in 1 August 2008.
1 April 2008
Quick facts
| Lead sponsor | Baxalta now part of Shire |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 1 January 2007 |
| Primary completion | 1 April 2008 |
| Estimated completion | 1 August 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Human Butyrylcholinesterase (HuBChE) derived from human plasma — full drug profile →
- Placebo: Normal saline
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Chemical Terrorism — all drugs for Chemical Terrorism →
- Chemical Warfare — all drugs for Chemical Warfare →
Sponsor
Baxalta now part of Shire — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers or Chemical Terrorism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dose regimen of human butyrylcholinesterase (HuBChE) in healthy adults at 3 ascending dosage levels administered IV. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers in each dosage cohort will be randomized to treatment with HuBChE active drug or normal saline placebo in a 3:1 ratio. The volunteers will remain in the study for 90 (+/- 7) days. For the first 3 days following dose administration, they will remain at the clinical trial site as inpatients and will be closely monitored for patient safety. Afterwards, they will return to the trial site (at pre-determined intervals) as outpatients for 8 further visits, where patient safety will be assessed.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Oligomerization status influences subcellular deposition and glycosylation of recombinant butyrylcholinesterase in Nicotiana benthamiana.
Schneider JD, Marillonnet S, Castilho A, Gruber C, et al · · 2014 · cited 25× · PMID 24618259 · DOI 10.1111/pbi.12184 -
Development of a long-acting Fc-fused cocaine hydrolase with improved yield of protein expression.
Chen X, Deng J, Zheng X, Zhang J, et al · · 2019 · cited 16× · PMID 30986387 · DOI 10.1016/j.cbi.2019.04.012 -
Kinetic characterization of a cocaine hydrolase engineered from mouse butyrylcholinesterase.
Chen X, Huang X, Geng L, Xue L, et al · · 2015 · cited 15× · PMID 25486543 · DOI 10.1042/bj20141266 -
Purification of human butyrylcholinesterase from frozen Cohn fraction IV-4 by ion exchange and Hupresin affinity chromatography.
Schopfer LM, Lockridge O, David E, Hinrichs SH. · · 2019 · cited 14× · PMID 30625168 · DOI 10.1371/journal.pone.0209795
Verify or expand the search:
- PubMed search for NCT00333515
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00333515 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baxalta now part of Shire
- Last refreshed: 5 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00333515.
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