Overview

Pharmacokinetic Study Protocol of ANAWIDOW Lyophilized Powder for Solution for Intravenous Use in Fasting Conditions

Status:
Active, not recruiting

Trial end date:
2021-11-01

Target enrollment:

Participant gender:

Summary

A single-dose, open-label, single-treatment, single-period pharmacokinetic study under fasting conditions, in 12 healthy adult. To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use.

Phase:

Phase 1

Details

Lead Sponsor:

Laboratorios Silanes S.A. de C.V.

Collaborator:

Rare Disease Therapeutics Inc.

Treatments:

Antivenins