Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers

A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of the Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers

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 fragment (INM004) in healthy volunteers.

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(ab')2 fragment (INM004) in 14 healthy subjects. This is a dose escalation study. Subjects will receive a single dose of an infusion of the biological product or placebo in Stage I where 2 cohorts will be assessed with 2 different doses of INM004. Subjects will receive a repeated dose (3 doses total, every 24 hs) of an infusion of the biological product or placebo in Stage II. The total duration of study participation is 4 weeks for each subject. Subjects will complete a follow-up visit at Day 30 after the dosing. Study duration is expected to last 6 months. The investigational product intent to use is for the prevention of the development of Hemolytic Uremic Syndrome (HUS) associated to Shigatoxin producing Escherichia coli (STEC).

Inclusion Criteria:

• 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 Criteria:

• 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.