220
Participants
Start Date
October 5, 2024
Primary Completion Date
July 28, 2025
Study Completion Date
September 28, 2025
INM004
Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragments at a dosage of 4 mg/kg of body weight, 24 hours apart. Each vial contains 25 mg of protein/ml. Therefore, each subject must receive 0.16 ml/kg per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes
Placebo
Two doses of placebo, 24 hours apart. The placebo solution has the same composition of excipients as INM004 without the active pharmaceutical ingredient, and its appearance is identical. Each subject must receive 0.16 ml/kg of placebo solution per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes
RECRUITING
Sanatorio Güemes, Buenos Aires
RECRUITING
"Hospital de Pediatría S.A.M.I.C. Prof. Dr. Juan P. Garrahan", Buenos Aires
NOT_YET_RECRUITING
Hospital General de Niños Pedro de Elizalde, Buenos Aires
RECRUITING
Sanatorio Anchorena, CABA
NOT_YET_RECRUITING
Hospital de niños Sor María Ludovica, La Plata
RECRUITING
"Hospital de Niños Zona Norte Dr. Roberto M. Carra", Rosario
RECRUITING
Hospital De Clínicas Pte. Nicolás Avellaneda, San Miguel de Tucumán
RECRUITING
Hospital Público Materno Infantil, Salta
RECRUITING
Hospital Privado Centro Médico de Córdoba, Córdoba
RECRUITING
Hospital Teodoro J. Schestakow, San Rafael
RECRUITING
Hospital Pediátrico San Luis, San Luis
RECRUITING
"Hospital San Antonio de Padua Río Cuarto", Río Cuarto
RECRUITING
Clinica del niño y la madre, Mar del Plata
NOT_YET_RECRUITING
Hospital Interzonal Dr. José Penna, Bahía Blanca
RECRUITING
Clínica Pediátrica San Lucas, Neuquén
RECRUITING
Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti, Mar del Plata
RECRUITING
Sanatorio de Niños, Rosario
RECRUITING
Clínica Zabala, Ciudad Autonoma de Buenos Aire
RECRUITING
Hospital de Niños Dr. Ricardo Gutierrez, Ciudad Autonoma de Buenos Aire
RECRUITING
Hospital de Niños de la Santísima Trinidad, Córdoba
RECRUITING
Sanatorio Allende, Córdoba
RECRUITING
Hospital Pediátrico Dr. Humberto Notti, Mendoza
NOT_YET_RECRUITING
Cliniques universitaires Saint-Luc, Brussels
NOT_YET_RECRUITING
CHU De Bordeaux, Bordeaux
NOT_YET_RECRUITING
Hospices Civils De Lyon - Hopital Femme Mere Enfant, Lyon
NOT_YET_RECRUITING
Centre Hospitalier Universitaire De Montpellier, Montpellier
NOT_YET_RECRUITING
Hospital Necker Enfants Malades, Paris
NOT_YET_RECRUITING
Robert Debre University Hospital, Paris
NOT_YET_RECRUITING
Trousseau Hospital, Paris
NOT_YET_RECRUITING
University Medical Center Hamburg-Eppendorf, Hamburg
NOT_YET_RECRUITING
Universitaetsklinikum Heidelberg AöR, Heidelberg
NOT_YET_RECRUITING
Children's Health Ireland, Dublin
NOT_YET_RECRUITING
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan
NOT_YET_RECRUITING
Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca, Cluj-Napoca
NOT_YET_RECRUITING
Bristol Royal Hospital for Children, Bristol
NOT_YET_RECRUITING
Great Ormon Street Hospital for Children, London
NOT_YET_RECRUITING
Royal Hospital for Sick Children, Glasgow
Lead Sponsor
Collaborators (3)
Exeltis
INDUSTRY
Chemo Research
INDUSTRY
Linical
UNKNOWN
KLIXAR
UNKNOWN
Inmunova S.A.
OTHER