Status:
COMPLETED
First Time in Human Study of Protexia
Lead Sponsor:
PharmAthene, Inc.
Collaborating Sponsors:
United States Department of Defense
Quintiles, Inc.
Conditions:
Intervention for Nerve Agent Exposure
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 nerv...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- Healthy male or female volunteers aged 18 to 55 years
- Willing to give written informed consent to participate in the study and to comply with all study requirements and procedures
- In the opinion of the Investigator, in generally good health, based upon pre-study medical history, physical examination, electrocardiogram (ECG) and laboratory tests
- Normal clinical chemistry, hematology and urinalysis results or clinically insignificant values during screening evaluations
- Women of childbearing potential may be enrolled if one of the following criteria applies:
- Using effective contraception (e.g., injectable, transdermal, vaginal ring, oral contraceptives, IUD or barrier methods) for at least three months prior to study entry, must have maintained a normal menstrual pattern for the 3 months prior to study entry and agree to continue contraception for the duration of their participation in the study.
- Females using injectable, transdermal, vaginal ring, oral contraceptives or an IUD must agree to augment this with a barrier method for the duration of their participation in the study.
- Is sexually abstinent
- Is monogamous with a vasectomized partner
- Is postmenopausal (i.e., no cycle for at least the previous 24 months and is of menopausal age (\> 45 years)
- Has not had a menstrual cycle for 12 to 24 months and is of menopausal age as described above
- Is surgically sterilized
- Has had a total hysterectomy a minimum of 3 months prior to dosing on Day 1
- 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
- Females in Group 3 will also require a negative serum pregnancy test on Day 71 prior to receiving Dose 2
- Sexually active male subjects may be enrolled if one of the following criteria applies:
- Has had a vasectomy
- Using condoms and whose partner is using an acceptable form of contraception (IUD, oral contraceptives, birth control patch or vaginal ring, injectable or implanted contraceptives, or tubal ligation \[surgical sterilization\]) for the duration of the study
- Is sexually abstinent
- Body Mass Index (BMI) 19 to 29, inclusive
- Abstinence from alcohol for 24 hours prior to study drug administration until discharge from the Phase I unit on Day 4
Exclusion
- Inability to provide Informed Consent
- Drug or alcohol abuse requiring treatment within 12 months of study screening
- Positive drug result at time of study screening or positive alcohol result at Day -1 (and Day 71 for Group 3 subjects)
- Use of cholinesterase inhibitors within 21 days of dosing
- Receipt of fresh frozen plasma within three months of study screening
- Allergy to milk or milk derived products
- History of allergic reaction to procainamide or to its metabolite, p-aminobenzoic acid
- Diagnosis of myasthenia gravis
- Participation in any trial of an investigational agent within 30 days of study screening
- Previous receipt of any investigational BChE product
- Clinically significant medical or psychiatric condition that, in the opinion of the Investigator, may impair study participation
- ECG with evidence of clinically significant conduction abnormalities or active ischemia at time of study screening
- Donation of one or more pints of blood within 30 days prior to study screening
- Known serum positivity for human immunodeficiency virus (HIV) antibodies, hepatitis B or hepatitis C
- Extensive tattooing which would preclude adequate assessment at the injection site(s)
- Females who are pregnant and/or breast feeding
- Use of systemic immunosuppressive agents, such as used to treat Alzheimer's Disease, within 3 months of dosing
- Use of dietary or herbal supplements within 3 months of dosing
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00744146
Start Date
September 1 2008
End Date
November 1 2009
Last Update
September 17 2010
Active Locations (1)
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1
Quinitles Phase I Services
Overland Park, Kansas, United States, 66211