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

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.

Timeline

Start

2021-07-01

Primary completion

2021-08-15

Completion

2022-02-15

Publications

• Background Ryan NM, Buckley NA, Graudins A. Treatments for Latrodectism-A Systematic Review on Their Clinical Effectiveness. Toxins (Basel). 2017 Apr 21;9(4):148. doi: 10.3390/toxins9040148.
• Background Vazquez H, Chavez-Haro A, Garcia-Ubbelohde W, Mancilla-Nava R, Paniagua-Solis J, Alagon A, Sevcik C. Pharmacokinetics of a F(ab')2 scorpion antivenom in healthy human volunteers. Toxicon. 2005 Dec 1;46(7):797-805. doi: 10.1016/j.toxicon.2005.08.010. Epub 2005 Sep 28.
• Background Offerman SR, Daubert GP, Clark RF. The treatment of black widow spider envenomation with antivenin latrodectus mactans: a case series. Perm J. 2011 Summer;15(3):76-81. doi: 10.7812/TPP/10-136.
• Background Dart RC, Bush SP, Heard K, Arnold TC, Sutter M, Campagne D, Holstege CP, Seifert SA, Lo JCY, Quan D, Borron S, Meurer DA, Burnham RI, McNally J, Garcia-Ubbelohde W, Anderson VE. The Efficacy of Antivenin Latrodectus (Black Widow) Equine Immune F(ab')2 Versus Placebo in the Treatment of Latrodectism: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Ann Emerg Med. 2019 Sep;74(3):439-449. doi: 10.1016/j.annemergmed.2019.02.007. Epub 2019 Mar 27.

Drugs

Indications