NCT04848714

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

Pharmacokinetic Study of ANAWIDOW [Antivenin Latrodectus (Black Widow) Equine Immune F(ab´)2] Solution 10 mL for Intravenous Use of Laboratorios Silanes, S.A. de C.V. in Healthy Adult Male and Female Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 of Laboratorios Silanes, S.A. de C.V. in healthy adult human male and female subjects under fasting conditions. To assess the safety of single dose of ANAWIDOW \[antivenin latrodectus (black widow) equine immune F(ab´)2\] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use in healthy adult human male and female subjects under fasting conditions. In a minimum of 12 healthy adult. In this study, all subjects will be required to fast overnight for at least 10.00 hours prior to dosing at least 04.00 hours post-dose. In this study, 3 ANAWIDOW 10 mL vials (3x10 mL) will be administered after diluting with normal saline solution up to 50 mL as intravenous infusion over 30 minutes. The solution will be infused through a 20-gauge catheter placed in the subject's left or right hand antecubital fossa at room temperature under fasting conditions.

Conditions

• Latrodectism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-08-15
• Completion: 2022-02-15
• First posted: 2021-04-19
• Last updated: 2022-03-02

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study