Healthy Volunteers Clinical Trial
Official title:
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
Verified date | February 2019 |
Source | Inmunova S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | September 28, 2018 |
Est. primary completion date | September 27, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Italiano de Buenos Aires | Ciudad Autónoma de Buenos Aire |
Lead Sponsor | Collaborator |
---|---|
Inmunova S.A. | Hospital Italiano de Buenos Aires |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 4 weeks | ||
Primary | Maximum Plasma Concentration [Cmax] | 4 weeks | ||
Primary | Area Under the Curve [AUC] | 4 weeks | ||
Primary | Elimination half-life (t½) | 4 weeks | ||
Primary | Time of Maximum concentration observed (Tmax) | 4 weeks | ||
Secondary | Number of participants with treatment-related hypersensitivity events as assessed by CTCAE v4.0 | 4 weeks |
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