14
Participants
Start Date
December 16, 2017
Primary Completion Date
September 27, 2018
Study Completion Date
September 28, 2018
Drug: INM004 Dose 1
Stage I- Cohort I: (2mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) -
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)
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).
Placebo
A placebo infusion will be administered at the same infusion rate as the Drug arm
Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aire
Lead Sponsor
Hospital Italiano de Buenos Aires
OTHER
Inmunova S.A.
OTHER