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

NCT03388216 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-02-27

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    collaborator OTHER

  • Inmunova S.A.

    lead OTHER

Principal Investigators

  • Santiago Sanguineti, Ph.D · Inmunova S.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-16
Primary Completion
2018-09-27
Completion
2018-09-28

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03388216 on ClinicalTrials.gov