|
|
|
|
|
|
Sponsors and Collaborators: |
PharmAthene, Inc. Department of Defense Quintiles QPS, LLC |
Information provided by: | PharmAthene, Inc. |
ClinicalTrials.gov Identifier: | NCT00744146 |
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.
Condition | Intervention | Phase |
Intervention for Nerve Agent Exposure |
Biological: Protexia |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 32 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 50 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
Biological: Protexia
Single 50 mg IM dose
|
2: Experimental
Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 100 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
Biological: Protexia
Single 100 mg dose
|
3: Experimental
Eight volunteers total. Randomized such that six volunteers will receive Protexia as a single 250 mg dose and two volunteers will receive saline placebo of the same volume on Study Days 1 and 72. Volunteers to be followed for approximately 142 days total. |
Biological: Protexia
Two 250 mg doses, IM, one at Day 1 and one at Day 72
|
4: Experimental
Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 500 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
Biological: Protexia
Single 500 mg dose, IM
|
5: Experimental
Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 750 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
Biological: Protexia
Single 750 mg dose, IM
|
Protexia is a pegylated form of recombinant human butyrylcholinesterase (PEG-rBChE). Butyrylcholinesterase (BChE) is a naturally-occurring enzyme found in minute quantities in the blood. PharmAthene produces PEG-rBChE from the milk of transgenic goats. The enzyme is purified from the goat milk, formulated and pegylated to create Protexia.
This is a dose escalation study of five dose levels of Protexia. Safety data through 14 days post-dosing will be evaluated by an independent Safety Monitoring Committee (SMC) prior to escalating to a higher dose. The safety and tolerability of Protexia will be assessed using the DMID Adult Toxicity Table, May 2001 (Appendix D).
If a dose limiting toxicity (DLT) is identified in any dosing group, dosing will be suspended until the AE(s) is/are assessed. The SMC will determine if the study can continue or if the previous dose will be declared the maximum tolerated dose (MTD). It is possible that an additional dosing group at a dose midway between the previous dosing group and the dose level that exceeded the MTD may be enrolled after consultation and agreement of the SMC.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women of childbearing potential may be enrolled if one of the following criteria applies:
Females with a negative urine pregnancy test at study Screening and a negative serum pregnancy test on admission to the Phase I unit at Day -1
Sexually active male subjects may be enrolled if one of the following criteria applies:
Exclusion Criteria:
Contact: Erin Nulf, RN | 800.292.5533 | vps.volunteer@quintiles.com |
United States, Kansas | |||||
Quinitles Phase I Services | Recruiting | ||||
Overland Park, Kansas, United States, 66211 | |||||
Contact: Erin Nulf, RN 800-292-5533 vps.volunteer@quintiles.com | |||||
Principal Investigator: Ralph A Schutz, MD | |||||
Sub-Investigator: Philip Leese, MD | |||||
Sub-Investigator: David Mathews, MD | |||||
Sub-Investigator: Eleanor Lisbon, MD | |||||
Sub-Investigator: Kelli Craven, MD | |||||
Sub-Investigator: Patricia Meier, MD |
PharmAthene, Inc. |
Department of Defense |
Quintiles |
QPS, LLC |
Principal Investigator: | Ralph A Schutz, MD | Quintiles |
Responsible Party: | PharmAthene, Inc. ( Valerie Riddle, M.D., Vice President and Medical Director ) |
Study ID Numbers: | QOPK 4439 |
First Received: | August 28, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00744146 |
Health Authority: | United States: Food and Drug Administration |
|