Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

December 16, 2017

Primary Completion Date

September 27, 2018

Study Completion Date

September 28, 2018

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

Drug: INM004 Dose 1

Stage I- Cohort I: (2mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) -

BIOLOGICAL

Drug: INM004 Dose 2

Stage I- Cohort II: Dose 2 (4mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo)

BIOLOGICAL

Drug: INM004- Repeated dose

Stage II: Either 3 doses of 2 mg/kg or 4 mg/kg will be administered every 24 hs. The ratio is 5:1 (investigational product : placebo).

OTHER

Placebo

A placebo infusion will be administered at the same infusion rate as the Drug arm

Trial Locations (1)

Unknown

Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aire

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hospital Italiano de Buenos Aires

OTHER

lead

Inmunova S.A.

OTHER