Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Interventions
- Other: Placebo
- Registration Number
- NCT03388216
- Lead Sponsor
- Inmunova S.A.
- 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 fragment (INM004) in healthy volunteers.
- 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(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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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Body mass index: between 19 and 27.
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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.
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Chest x-ray and electrocardiogram within normal ranges.
-.Willing to participate and sign the informed consent.
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Women of child-bearing potential using at least two barrier birth control methods.
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Sexually active men using medically accepted birth control methods, such as condom with spermicide.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stage I - Placebo Dose 1 Placebo - Stage I- Placebo Dose 2 Placebo - Stage II- Placebo Repeated Dose Placebo -
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 4 weeks Time of Maximum concentration observed (Tmax) 4 weeks Area Under the Curve [AUC] 4 weeks Maximum Plasma Concentration [Cmax] 4 weeks Elimination half-life (t½) 4 weeks
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related hypersensitivity events as assessed by CTCAE v4.0 4 weeks
Trial Locations
- Locations (1)
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina