NCT00744146

Phase I, Randomized, Controlled, Third-party Double-blind, Dose Escalating Study of Protexia Administered Intramuscularly at One or Two Time Points in Healthy Human Volunteers

Completed Phase 1 Last updated 16 September 2010

What this trial tests

Phase 1 trial testing Protexia in Intervention for Nerve Agent Exposure in 33 participants. Completed in 1 November 2009.

Timeline

1 September 2008

Primary endpoint
1 July 2009

1 November 2009

Quick facts

Lead sponsor	PharmAthene, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	33
Start date	1 September 2008
Primary completion	1 July 2009
Estimated completion	1 November 2009
Sites	1 location across United States

Drugs / interventions tested

• Protexia — full drug profile →
• Protexia — full drug profile →
• Protexia — full drug profile →
• Protexia — full drug profile →
• Protexia — full drug profile →

Conditions studied

• Intervention for Nerve Agent Exposure — all drugs for Intervention for Nerve Agent Exposure →

Sponsor

PharmAthene, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Intervention for Nerve Agent Exposure. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety will be assessed by: - The determination of dose limiting toxicity (if reached) - Changes from baseline for clinical laboratory tests, urine tests and vital signs - Descriptive statistics for adverse events and safety parameters
  Time frame: Volunteers in 4 of 5 Groups will be followed for 72 days. Volunteeers in 1 group will be followed for 142 days.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of Protexia, an experimental drug being developed to protect soldiers against the effects of nerve agents.

Volunteers will be entered into one of five groups. Four of the groups will receive a single intramuscular dose of Protexia or saline placebo on Study Day 1 and will participate in the study for approximately 71 days. One of the groups will receive two intramuscular doses of Protexia or saline placebo - one dose on Study Day 1 and the second dose on Study Day 72. This group will participate in the study for approximately 142 days.

All volunteers will remain at the study site as an inpatient for three days after they are dosed and will be monitored closely by the study doctors and staff. After that, volunteers will return to the study site as outpatients at predetermined intervals. Groups 1, 2, 4, 5 will have a total of 6 follow-up visits and Group 3 will have a total of 12 follow-up visits.

It is expected that this study will provide important information on the safety and tolerabiity of Protexia at one and two doses.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Plant-derived human butyrylcholinesterase, but not an organophosphorous-compound hydrolyzing variant thereof, protects rodents against nerve agents.
   Geyer BC, Kannan L, Garnaud PE, Broomfield CA, et al · · 2010 · cited 56× · PMID 21059932 · DOI 10.1073/pnas.1009021107
2. Technoeconomic analysis of semicontinuous bioreactor production of biopharmaceuticals in transgenic rice cell suspension cultures.
   Corbin JM, McNulty MJ, Macharoen K, McDonald KA, et al · · 2020 · cited 21× · PMID 32592492 · DOI 10.1002/bit.27475
3. Dimerization of human butyrylcholinesterase expressed in bacterium for development of a thermally stable bioscavenger of organophosphorus compounds.
   Cai Y, Zhou S, Stewart MJ, Zheng F, et al · · 2019 · cited 5× · PMID 31325422 · DOI 10.1016/j.cbi.2019.108756
4. Selection of a human butyrylcholinesterase-like antibody single-chain variable fragment resistant to AChE inhibitors from a phage library expressed in E. coli.
   Podestà A, Rossi S, Massarelli I, Carpi S, et al · · 2014 · cited 1× · PMID 24675419 · DOI 10.4161/mabs.28635