Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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 of muscle paralysis in Stage A. 2. To assess the ability of botulism antitoxin (heptavalent, Cangene) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage B.

Key facts

Study ID

NCT00636519

Run by

Emergent BioSolutions

People needed

36

Starts

2008-02-01

Expected to finish

2009-10-01

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dr. Gordon Peterson — Loma Linda, California, United States
• R. Richard Sloop, M. D. — Yakima, Washington, United States

Full record on ClinicalTrials.gov

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