None listed
Conditions
Brief summary
Hendra Virus Monoclonal Antibody (mAb m102.4) is an experimental drug product which is administered through a drip (infusion) into a vein in the forearm. It is a human monoclonal antibody which has been man-made and is being developed as a potential treatment for Hendra virus infection. This product is not a vaccine against Hendra virus infection. The purpose of this study is to test the safety of monoclonal antibodies designed to act against Hendra virus. Our aim is to find out more about mAb m102.4 when it is administered to healthy individuals. The main objective of the study is to evaluate the safety and tolerability of mAb m102.4. That is to find out how it makes people feel and whether there are any side effects or changes to laboratory results. We will also determine the amount of mAb m102.4 in your blood at various times during the study, its effect on your immune system as well as the extent of its anti-virus activity.
Interventions
Human monoclonal antibody (IgG1), m102.4
Subjects will be dosed with four IV concentrations of monoclonal antibody m102.4 across five cohorts (8 participants in each cohort). The first four cohorts (Cohorts 1 to 4) will receive a single, IV infusion of mAb m102.4 at a concentration of 1 mg/kg, 3 mg/kg, 10 mg/kg or 20 mg/kg over a period of 1 hour. The fifth cohort (Cohort 5) will receive two IV infusions of mAb m102.4 at a concentration of 20 mg/kg given over the period of 1 hour, with 72 hour
Human monoclonal antibody (IgG1), m102.4 Subjects will be dosed with four IV concentrations of monoclonal antibody m102.4 across five cohorts (8 participants in each cohort). The first four cohorts (Cohorts 1 to 4) will receive a single, IV infusion of mAb m102.4 at a concentration of 1 mg/kg, 3 mg/kg, 10 mg/kg or 20 mg/kg over a period of 1 hour. The fifth cohort (Cohort 5) will receive two IV infusions of mAb m102.4 at a concentration of 20 mg/kg given over the period of 1 hour, with 72 hours between each infusion
Sponsors
Queensland Department of Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Outcome results
None listed