Status:
COMPLETED
Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses
Lead Sponsor:
Emergent BioSolutions
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin Serotypes derived from horses using various laboratory measurements, clinical examinations and adverse events. I...
Detailed Description
Clostridial toxins are amongst the most toxic substances known to science (Middlebrook, 1995). In the United States and other countries, human exposure to Clostridium botulinum toxins usually occurs t...
Eligibility Criteria
Inclusion
- Body-mass index of 20 to 30 with minimum body weight of 111 lb (50 kg).
- For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including:
- Using hormonal contraception (oral or injectable or implant) continuously for 3 months prior to the start of the trial and willing to continue to use hormonal contraception throughout the entire trial.
- IUD inserted at least 2 months prior to dosing.
- For female subjects who are postmenopausal less than 2 years an FSH \>= 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.
- Normal and healthy as determined by medical history, physical examination, ECG, vital signs and test of liver, kidney and hematological functions.
- Written Informed Consent
Exclusion
- 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 products containing horse serum)
- Any severe food allergies, seasonal allergies or hay fever requiring therapy such as treatment with immunosuppressive drugs
- Known acute or chronic asthma requiring treatment with immunosuppressive drugs
- History of hypersensitivity to blood products derived from a human or equine source
- Heavy smokers (\>10 cigarettes a day)
- Use of nicotine containing products
- Use of any investigational product within the past 30 days
- Pregnancy or lactation
- Positive serological test for HIV, HBV, or HCV
- History of, or suspected substance abuse problem (including alcohol) or failure of alcohol or drug screen at screening or at baseline
- Individuals with a history of allergy to latex or rubber
- Hemoglobin level of \< 12 g/dL.
- Significant blood loss or blood donation within 56 days prior to dosing.
- Any plasma donation within 7 days prior to dosing.
- Demonstrated potential for allergic reaction to NP-018 based on positive horse dander (E3) IgE test or positive NP-018 skin sensitivity test prior to dosing
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00360737
Start Date
July 1 2006
End Date
April 1 2010
Last Update
March 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MDS Pharma Services
Phoenix, Arizona, United States, 85044