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

Inmunova S.A.1 site in 1 country14 target enrollmentDecember 16, 2017

ConditionsHealthy Volunteers

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Inmunova S.A.
Enrollment: 14
Locations: 1
Primary Endpoint: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 16, 2017

End Date

September 28, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Inmunova S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index: between 19 and
•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