Status:
COMPLETED
Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
Lead Sponsor:
Inmunova S.A.
Collaborating Sponsors:
Hospital Italiano de Buenos Aires
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fr...
Detailed Description
This is a study that will be conducted at a single site in Argentina to characterize the Pharmacokinetics (PK) profile, safety and tolerability of anti-Shiga toxin hyperimmune equine immunoglobulin F(...
Eligibility Criteria
Inclusion
- Body mass index: between 19 and 27.
- Healthy subject, as determined by clinical exam, medical history and laboratory tests (chemistry, hematology and urine, pregnancy test if applicable) performed during the screening visit.
- Chest x-ray and electrocardiogram within normal ranges.
- .Willing to participate and sign the informed consent.
- Women of child-bearing potential using at least two barrier birth control methods.
- Sexually active men using medically accepted birth control methods, such as condom with spermicide.
Exclusion
- Known hypersensitivity to equine serum.
- Hypersensitivity to any of the components of the pharmaceutical preparation.
- History of severe allergic reactions to any type of antigen.
- History of mental illness.
- Participation in another clinical research study within 90 days6 months prior to the start of this study
- History of alcohol or drug abuse.
- History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, hematological, neurological disease.
- Having received contrast substances for radiological studies of any kind in the two weeks prior to the start of the study.
- Receiving or having received any prescription drug within the two weeks prior to the start of the study, including oral contraceptives in women of child-bearing potential.
- Having received more than three doses of any over-the-counter medication during the week prior to the start of the study or any medication within two days prior to the hospitalization
- Having given blood within a period of under 2 months prior to the start of the study
- Documented infection with HIV, hepatitis B and/or hepatitis C.
- Pregnancy
- History of asthma, allergy, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
- History of vaccination within the month prior to the start of the study.
- Infectious disease requiring hospitalization within the month prior to the inclusion in the study.
- Having received a transfusion of blood products within three months prior to the inclusion in the study
- Having received any medication within 14 days prior to the inclusion in the study.
- Family relation or work relation to the personnel of the research group.
Key Trial Info
Start Date :
December 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03388216
Start Date
December 16 2017
End Date
September 28 2018
Last Update
February 27 2019
Active Locations (1)
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1
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aire, Argentina