A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00333528
• Date of registration: 01/06/2006
• Primary sponsor: Baxter Healthcare Corporation
• Public title: A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly
• Scientific title: A Phase 1, Randomized, Observer-Blinded, Single Dose, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Plasma-Derived Human Butyrylcholinesterase (HuBChE) Administered Intramuscularly (IM)
• Date of first enrolment: December 2007
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00333528
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ralph A Schutz, MD
• Affiliation: Quintiles (Clinical Research Organization)

Key inclusion & exclusion criteria

Inclusion Criteria:

- The volunteer is between 18 and 55 years of age (inclusive) at the time of
administration of HuBChE.

- The volunteer is in good health as determined by the Investigator (Study Doctor) from
a medical history and physical examination.

- The volunteer has clinical chemistry, hematology, coagulation, and urinalysis
laboratory values within acceptable ranges or deemed clinically insignificant by the
Principal Investigator (PI) and Project Medical Monitor.

- The volunteer has a normal electrocardiogram (ECG) or one with clinically
insignificant findings as deemed by the PI.

- The volunteer is willing to have his or her blood samples stored for future HuBChE
research studies.

- The volunteer has signed the Informed Consent Form (ICF) and has signed the Health
Insurance Portability and Accountability Act (HIPAA) authorization form.

- The volunteer agrees not to donate blood during the trial or for at least 2 months
following the 90 day study visit.

- The volunteer is willing to comply with the requirements of the protocol through the
Post-Infusion Day 90 (± 7 days) visit.

- Female volunteers must be of non-childbearing potential (i.e., surgically sterilized
or postmenopausal), or must not be pregnant (as indicated by a negative urine
pregnancy test within 1 day prior to HuBChE administration) or nursing, and must use
two types of acceptable forms of Food and Drug Administration (FDA) approved birth
control methods, including:

- Progesterone only hormonal types of birth control (such as implants or birth
control pills) or an intrauterine device (IUD) and

- an additional barrier type of birth control measure (i.e., condoms, diaphragms,
cervical caps, etc.) during the period beginning from 30 days before HuBChE
administration through completion of the study. Completion of the study is
defined as completing the acute phase of the study (Day 45 [± 3 days] visit).

Exclusion Criteria:

- The volunteer demonstrates predisposition to thrombus formation as determined by past
medial history, and family history.

- The volunteer has a history of anaphylactoid reaction or other serious adverse
reactions to blood products.

- The volunteer has a history of allergic reaction to procainamide or to its
metabolite, p-aminobenzoic acid.

- The volunteer has been diagnosed with alcohol or drug abuse within the 12 months
prior to study screening or offers a history of alcohol or drug abuse within the 12
months prior to screening.

- The volunteer has a positive result on a urine drug screen that tests for common
substances of abuse, such as amphetamines, barbiturates, benzodiazepines, cocaine,
opiates and cannabinoids. (If positive on screen, confirmatory testing shall be
performed where applicable.)

- The volunteer has a previous diagnosis of any serious psychiatric disorder. For this
purpose, serious psychiatric disorder is defined as illness requiring hospitalization
within the previous 12 months; routine administration of more than one medication to
control anxiety, mood or sleep disorder; or history of suicide attempt.

- The volunteer has received any blood products or immune globulin in the previous six
months.

- The volunteer has donated blood within 56 days prior to receipt of study product (Day
0).

- The volunteer has a deficiency of immunoglobulin A (IgA) as determined on screening.

- The volunteer has a current or past medical history for any condition which, in the
opinion of the PI and/or Project Medical Monitor (PMM), might place him or her at
risk by participating in the study.

- Personal or family history (in first degree relatives) of significant neuromuscular
disease (as determined by the PI).

- Female volunteer is pregnant (must have a negative urine pregnancy test within 1 day
of receipt of HuBChE), lactating, or unwilling to use 2 types of an acceptable
FDA-approved form of contraception from time of screening through completion of the
Day 45 (± 1 day) study visit.

- Current use, receipt within the previous 14 days, or intent to use during the 14 days
after receiving drug product of drugs that may be metabolized, inhibited or otherwise
affected by BChE.

- The volunteer has a clinically significant abnormality on the ECG.

- The volunteer has any laboratory values outside acceptable ranges that are clinically
significant as assessed by the Investigator and/or PMM.

- The volunteer tests positive for HIV, HCV or HBV at screening.

- The volunteer has an acute illness, evidence of significant active infection, or
evidence of systemic disease at time of enrollment that in the opinion of the PI
would place the volunteer at an unacceptable risk for injury.

- The volunteer has a temperature >100.4°F at the time of dose administration.

- The volunteer has occupational or other responsibilities that would prevent
completion of participation in the study.

- The volunteer is currently using tobacco products.

- Participants in other clinical trials in the past 60 days.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Human butyrylcholinesterase (HuBChE) derived from human plasma

Drug: Placebo: Normal saline

Primary Outcome(s)

Frequency and severity of local and systemic adverse events (AEs) [Time Frame: until post-infusion Day 90 (+/- 7 days)]

Secondary ID(s)

HuBChE-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DynPort Vaccine Company LLC, A CSC Company