Clinical trial NCT03388216: Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Inmunova S.A.
Sponsor class: OTHER
Collaborators: name: Hospital Italiano de Buenos Aires
First posted: 2018-01-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 4 weeks
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 4 weeks
measure: Area Under the Curve [AUC]
timeFrame: 4 weeks
measure: Elimination half-life (t½)
timeFrame: 4 weeks
measure: Time of Maximum concentration observed (Tmax)
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of participants with treatment-related hypersensitivity events as assessed by CTCAE v4.0
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Inmunova S.A.
name: Santiago Sanguineti, Ph.D
role: STUDY_DIRECTOR
References: