NCT03388216

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Inmunova S.A. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-16
• Primary completion: 2018-09-27
• Completion: 2018-09-28
• First posted: 2018-01-02
• Last updated: 2019-02-27

Locations

1 site across 1 country: Argentina