NCT04848714View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

August 15, 2021

Study Completion Date

February 15, 2022

Conditions
Latrodectism
Interventions
DRUG

ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL

Antivenin latrodectus (black widow) equine immune F(ab)2\] lyophilized powder for solution 10 mL for intravenous use \[parenteral formulation\]; hence, a single-dose fasting pharmacokinetic study is planned.

Trial Locations (1)

11000

Laboratorio Silanes, S.A. de C.V., Mexico City

All Listed Sponsors
collaborator

Rare Disease Therapeutics Inc.

OTHER

lead

Laboratorios Silanes S.A. de C.V.

INDUSTRY