Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses

Completed · Phase 1

Conditions studied: Healthy

In brief

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. In addition, following intravenous (injected into the vein) administration assessing how much 7 Botulinum Antitoxin remains in the body.

Key facts

Study ID

NCT00360737

Run by

Emergent BioSolutions

People needed

40

Starts

2006-07-01

Expected to finish

2010-04-01

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…

• 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

You may not qualify if…

• 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

Where it is running

• MDS Pharma Services — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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