Healthy VolunteersPhase 1NCT00333528
A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly
A Phase 1 study testing Human butyrylcholinesterase (HuBChE) derived from human plasma in people with Healthy Volunteers, run by Baxalta now part of Shire at 1 site in United States.
Trial summary
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Human butyrylcholinesterase (HuBChE) derived from human plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2007to 1 Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion of either HuBChE or normal saline placebo. The volunteers will remain in the study for 90 (+/- 7) days. For the first 3 days following dose administration, they will remain at the clinical trial site as an inpatient and will be closely monitored for patient safety. Afterwards, they will return to the trial site (at pre-determined intervals) as an outpatient for a further 8 visits, where patient safety will be assessed.
- Conditions
- Healthy Volunteers
- Being tested
- Human butyrylcholinesterase (HuBChE) derived from human plasma, Placebo: Normal saline
- Keywords
- Chemical Warfare Agents, Chemical Nerve Agent Intoxication, Chemical Terrorism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human butyrylcholinesterase (HuBChE) derived from human plasmaDrug
Intramuscular administration
Placebo: Normal salineDrug
Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of one dose of the active drug (6 volunteers) Receives: Drug: Human butyrylcholinesterase (HuBChE) derived from human plasma |
| 2 | Placebo comparator | Administration of placebo (2 volunteers) Receives: Drug: Placebo: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of local and systemic adverse events (AEs)
Measured: until post-infusion Day 90 (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study start1 Dec 2007
- Primary completion1 Apr 2008
- Study completion1 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DynPort Vaccine Company LLC, A GDIT Company
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333528
- Sponsor's protocol ID
- HuBChE-02
- Status last verified
- May 2021
- First submitted
- 1 Jun 2006
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00333528
- Acronym / sponsor ID
- HuBChE-02
- Conditions
- Healthy Volunteers
- Keywords
- Chemical Warfare Agents, Chemical Nerve Agent Intoxication, Chemical Terrorism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- DynPort Vaccine Company LLC, A GDIT Company
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 1 Apr 2008 (actual)
- Study completion
- 1 Aug 2008 (actual)
- First posted
- 5 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion of either HuBChE or normal saline placebo. The volunteers will remain in the study for 90 (+/- 7) days. For the first 3 days following dose administration, they will remain at the clinical trial site as an inpatient and will be closely monitored for patient safety. Afterwards, they will return to the trial site (at pre-determined intervals) as an outpatient for a further 8 visits, where patient safety will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Human butyrylcholinesterase (HuBChE) derived from human plasmaAdministration of one dose of the active drug (6 volunteers) |
| 2 | Placebo comparator | Drug: Placebo: Normal salineAdministration of placebo (2 volunteers) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human butyrylcholinesterase (HuBChE) derived from human plasmaIntramuscular administration | Drug | 1 |
| Placebo: Normal salineIntramuscular administration | Drug | 2 |
Primary outcome
Frequency and severity of local and systemic adverse events (AEs)
Time frame: until post-infusion Day 90 (+/- 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human butyrylcholinesterase (HuBChE) derived from human plasma in people with Healthy Volunteers, run by Baxalta now part of Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of local and systemic adverse events (AEs) (time frame: until post-infusion Day 90 (+/- 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.