A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Various Dosing Regimens of Intravenous anti-Hendra Virus Antibody (mAb m102.4) in Healthy Subjects

Phase 1

Completed

• Conditions: Hendra virus infection; Infection - Other infectious diseases

• Registration Number: ACTRN12615000395538
• Lead Sponsor: Queensland Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Healthy males and females between 18 and 50 years of age Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine;
Willing to attend all the study visits

Exclusion Criteria

Close, unprotected exposure to sick horses with an unexplained illness within 4 weeks of Day 1; or known exposure to potential Hendra infected horses;
Suffering acute or chronic disease
Use of potential drugs of abuse (including alcohol & cigerettes)
Excessive use of caffeine-containing beverages
Treatment with an investigational drug or biologic within 60 days preceding treatment or plans to take another in the 3 months following IP administration
Blood donation / plasma donation or significant blood loss 60 days prior to Day 1
Poor peripheral venous access
Subject is on staff at the investigator site; or a relative of personnel of the investigator site or of the Sponsor
Use of prescription or non-prescription drugs within 14 days prior to IP administration and for the duration of the study
Presence or history of drug hypersensitivity, or severe allergic reaction following any vaccination or infusion
Any vaccination in the last month
Pregnant or breastfeeding females, females (and males who have female partners) who are capable of becoming pregnant and who have not had surgery to become sterilized and who are not using an effective method of birth control.

Study & Design

• Study Type: Interventional
• Study Design: Not specified