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Trial registered on ANZCTR


Registration number
ACTRN12615000395538
Ethics application status
Approved
Date submitted
25/03/2015
Date registered
29/04/2015
Date last updated
29/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
A Phase 1, 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
Secondary ID [1] 286304 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hendra virus infection 294395 0
Condition category
Condition code
Infection 294703 294703 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 291341 0
Treatment: Other
Comparator / control treatment
Placebo (normal saline, prepared to maintain the blind) that is identically matched to the Investigational Product (IP) and unable to be distinguished from the IP to those who are blinded.
Control group
Placebo

Outcomes
Primary outcome [1] 294466 0
Safety
Timepoint [1] 294466 0
Safety assessments (pathology, vital signs & ECG) for Cohort 1-4 will be conducted upon admission to the CRU, at baseline (Day 1) and during the clinical stay. Subjects will return to the CRU on Days 4, 6, 8, 15, 22, 29, 43, 57, 85 and 113 for PK and immunogenicity sampling and/or safety assessments.

Safety assessments for Cohort 5 will be conducted upon admission to the CRU, at baseline (Day 1) and during the clinical stay. Subjects will return to the CRU on Days 7, 9, 11, 18, 25, 32, 39, 53, 67, 95 and 123 for PK and immunogenicity sampling and/or safety assessments.
The final safety assessment is scheduled for a maximum of 16 weeks after the last dose of IP. This is based on a mAb m102.4 t½ of 21-23 days.


Primary outcome [2] 294748 0
Tolerability
Timepoint [2] 294748 0
Subjects in cohort 1-4 will be assessed for tolerability (adverse events and concomitant medications) on days 1,2,3,4,6,8,15,22,29,43,57,85 & 113.

Subjects in cohort 5 will be assessed for tolerability (adverse events and concomitant medications) on days 1,2,3,4,5,6,7,8,9,11,15,18,25,32,53,67,95 &123.
Primary outcome [3] 294749 0
Pharmacokinetics (PK)
Timepoint [3] 294749 0
PK will be performed using serum assay for the monoclonal antibody.

For cohorts 1-4, PK samples will be taken on days 1,2,4,6,8,15,29,43,85 & 113.

For cohort 5 PK samples will be taken on days 1,2,3,4,5,7,11,18,32,53,95 &123
Secondary outcome [1] 313668 0
Immunogenicity
Timepoint [1] 313668 0
The test used for this is an anti drug assay (ADA). Immunogenicity will be assessed pre dose and on Days 29 and 113 for Cohorts 1-4 and pre-dose and on Days 39 and 123 for Cohort 5.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be assigned a sequential screening number at their Screening visit. Eligible subjects be randomized on the morning of Day 1 and will be allocated a randomization number. Each subject will have a corresponding IP or placebo allocated on the randomization list. The two sentinel subjects in each cohort will be dosed first. In accordance with the randomization list one subject from the sentinel pair will receive IP and the other will receive placebo. The remaining six subjects per cohort will be randomized to receive either IP or placebo in a 5:1 ratio. For each cohort, a set of sealed, opaque, tamper-evident Individual Codebreak Envelopes will be prepared and provided to the Site. In order to maintain the study blind the randomization list will only be available to the un-blinded pharmacist and will be held in a secure location with restricted access
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be allocated their treatment according to a computer generated randomisation schedule. The generation of the Randomisation List for each cohort will be performed using SAS Registered Trademark v9.4 or later
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
The sample size for this study was not based on statistical power calculation, but is consistent with the typical sample size used for similar studies to assess preliminary safety, PK and immunogenicity data

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290864 0
Government body
Name [1] 290864 0
Queensland Department of Health
Address [1] 290864 0
147-163 Charlotte Street, Brisbane, Queensland, 4001
Country [1] 290864 0
Australia
Funding source category [2] 290865 0
Other Collaborative groups
Name [2] 290865 0
National Hendra Virus Research Program
Address [2] 290865 0
Office of the NSW Chief Scientist and Engineer, GPO Box 5477, Sydney, NSW, 2001
Country [2] 290865 0
Australia
Funding source category [3] 290866 0
Government body
Name [3] 290866 0
National Health and Medical Research Council
Address [3] 290866 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [3] 290866 0
Australia
Primary sponsor type
Government body
Name
Queensland Department of Health
Address
147-163 Charlotte Street, Brisbane, Queensland, 4001
Country
Australia
Secondary sponsor category [1] 289556 0
None
Name [1] 289556 0
Address [1] 289556 0
Country [1] 289556 0
Other collaborator category [1] 278380 0
University
Name [1] 278380 0
Australian Institute of Bioengineering and Nanotechnology, University of Queensland
Address [1] 278380 0
Australian Institute for Bioengineering
and Nanotechnology (AIBN)
Corner College and Cooper Rds (Bldg 75)
The University of Queensland
Brisbane Qld 4072
Australia
Country [1] 278380 0
Australia
Other collaborator category [2] 278381 0
Commercial sector/Industry
Name [2] 278381 0
Q-Pharm Pty Limited
Address [2] 278381 0
Level 5 (Clinic and Recruitment & Outpatients)
Clive Berghofer Cancer Research Centre (CBCRC)
300C Herston Road
Herston
QLD 4006
Country [2] 278381 0
Australia
Other collaborator category [3] 278382 0
Government body
Name [3] 278382 0
Australian Animal Health Laboratory
Address [3] 278382 0
Cnr Portarlington and Boundary Roads
East Geelong VIC 3219
Australia
Country [3] 278382 0
Australia
Other collaborator category [4] 278383 0
University
Name [4] 278383 0
Uniformed Services University of the Health Sciences
Address [4] 278383 0
4301 Jones Bridge Road, Bethesda, MD, United States of America, 20814

Country [4] 278383 0
United States of America
Other collaborator category [5] 278407 0
Charities/Societies/Foundations
Name [5] 278407 0
Henry M Jackson Foundation for the Advancement of Military Medicine
Address [5] 278407 0
6720A Rockledge Drive, Suite 100
Bethesda, Maryland, USA 20817

Country [5] 278407 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292480 0
QIMR Berghofer Human Research Institute HREC
Ethics committee address [1] 292480 0
QIMR Locked Bag 2000
Royal Brisbane and Women's Hospital
HERSTON QLD 4029
Ethics committee country [1] 292480 0
Australia
Date submitted for ethics approval [1] 292480 0
Approval date [1] 292480 0
02/03/2015
Ethics approval number [1] 292480 0
P2050

Summary
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.
Trial website
Trial related presentations / publications
Pending
Public notes

Contacts
Principal investigator
Name 55498 0
Dr Geoffrey Playford
Address 55498 0
Q-Pharm Pty Limited
QIMR Berghofer CBCRC, Level 5
300C Herston Rd.
Brisbane, QUEENSLAND 4006
Country 55498 0
Australia
Phone 55498 0
(+61) 07 38453636
Fax 55498 0
Email 55498 0
geoffrey.playford@health.qld.gov.au
Contact person for public queries
Name 55499 0
Ms Kate Lynch
Address 55499 0
Communicable Diseases Unit, Queensland Department of Health. 15 Butterfield Street, HERSTON QLD 4006
Country 55499 0
Australia
Phone 55499 0
(+61) 07 3328 9735
Fax 55499 0
Email 55499 0
kate.lynch@health.qld.gov.au
Contact person for scientific queries
Name 55500 0
Dr Geoffrey Playford
Address 55500 0
Infection Management Services Administration
Level 1, Building 17
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 55500 0
Australia
Phone 55500 0
(+61) 07 3328 9735
Fax 55500 0
Email 55500 0
geoffrey.playford@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary