First Time in Human Study of Protexia

NCT00744146 | Completed Phase 1 DMC

• 1 other identifier: QOPK 4439
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Intervention for Nerve Agent Exposure

Outcome Measures

Primary Outcomes (1)

• 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

  Volunteers in 4 of 5 Groups will be followed for 72 days. Volunteeers in 1 group will be followed for 142 days.

Secondary Outcomes (1)

• Pharmacokinetics and immunogenicity will be assessed.

  Volunteers in 4 of 5 Groups will be followed for 72 days. Volunteeers in 1 group will be followed for 142 days.

Study Arms (5)

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

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

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

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

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

Interventions

Protexia BIOLOGICAL

Single 50 mg IM dose

Also known as: PEG-rBChE

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PharmAthene, Inc.: lead
• United States Department of Defense: collaborator
• Quintiles, Inc.: collaborator
• QPS Holdings LLC: collaborator

Study Sites (1)

Quinitles Phase I Services

Overland Park, Kansas, 66211, United States

Location

Study Officials

• Ralph A Schutz, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

US (1)