Status:
COMPLETED
Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle
Lead Sponsor:
Emergent BioSolutions
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is: 1. To evaluate the model determined by the ability of botulism antitoxin (bivalent, Aventis) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model...
Detailed Description
Botulism is a rare disease; however Botulinum toxins (neurotoxins) may be used as biological weapon especially in the form of aerosol. Botulism is caused by neurotoxins that are produced by the obliga...
Eligibility Criteria
Inclusion
- Male or female
- Age 18 - 55 years
- Body-mass index 19-30
- Normal and healthy as determined by medical history, physical examination, ECG, NCS, vital signs and tests of liver, kidney and hematological functions
- Adequate form of contraception for female subjects
- For women with child-bearing potential-using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to the start of the study and willing to continue to use hormonal contraception throughout the entire study. IUD inserted or use of condoms for at least 2 months prior to dosing
- Other forms of contraception may be considered as adequate at physician's discretion
- Surgically-sterilized female subjects
- For female subjects who are postmenopausal, an FSH ≥ than 40 mIU/mL must be obtained. If the FSH is \< 40 mIU/mL the subject must agree to use an acceptable form of contraception (see above for acceptable forms of contraception)
- Signed written Informed Consent
Exclusion
- Previously injected with BOTOX®, BOTOX® COSMETIC or MYOBLOC®
- Any known or documented Botulinum infection/intoxication
- Any known or documented allergies to horses (e.g. rash, wheezing, rhinitis etc. after exposure to horses)
- Any known or documented allergies to horse serum (observation of adverse events after treatment with any kind of product containing horse serum)
- Any moderate or severe food allergies, seasonal allergies or hay fever requiring treatment with peroral or parenteral immunosuppressive drug
- Any known or documented hypersensitivity to blood products derived from a human or equine source
- Any known or documented hypersensitivity to albumin
- Positive result for Botulism Antitoxin skin sensitivity testing
- Any known or documented allergy to rubber, latex or plastic
- Known acute or chronic moderate or severe asthma requiring treatment with peroral and / or parenteral immunosuppressive drugs
- Previously diagnosed or currently suspected Multiple Sclerosis or other neuromuscular degenerative disorder
- Previously diagnosed or currently suspected motor neuron disease
- Previously or currently diagnosed peripheral neuropathy of lower extremities' nerves
- Current infection of the skin / skin problems at the injection site (foot)
- Scar tissue or tattoo of the skin over the extensor digitorum brevis muscles.
- Previously diagnosed or currently suspected diabetes
- Previously diagnosed or currently suspected coagulopathies
- Previously diagnosed or currently suspected vasculitis
- Current treatment or treatment in the past 7 days with aminoglycosides, clindamycin, quinolines or aminopyridine
- Heavy smokers (\>10 cigarettes/day)
- History of, or suspected substance abuse (including alcohol) or failure of drug screen at screening or at baseline
- Use of any investigational product within the past 30 days (prior to screening)
- Pregnancy or lactation
- Positive serological test for diagnosis of HIV infection, HBV hepatitis, or HCV hepatitis
- Abnormal (based on principle investigator assessment) nerve conduction study (NCS) results
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00636519
Start Date
February 1 2008
End Date
October 1 2009
Last Update
March 18 2024
Active Locations (2)
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1
Dr. Gordon Peterson
Loma Linda, California, United States, 92354
2
R. Richard Sloop, M. D.
Yakima, Washington, United States, 98902