The Chair opened the meeting at 1pm and welcomed Committee members, noting that apologies had been received from Dr Catherin Jackson. The noted that Ms Toni Millar was attending in an observational capacity and was not reviewing applications. The Chair noted that the meeting was quorate. The Committee noted and agreed the agenda for the meeting. Confirmation of previous minutes The minutes of the meeting of 11 October were confirmed. New applications 1 Ethics ref: 16/NTA/188 A study of RO7062931 in healthy subjects and patients chronically infected with hepatitis B virus infection Principal Investigator: Professor Ed Gane Sponsor: Covance NZ Ltd Clock Start Date: 03 November 2016 Dr Paul Hamilton and Ms Mary Ellis-Peglar were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The study is a phase I clinical trial of the study drug, RO7062931, to test its’ safety and tolerability in human subjects. The Committee noted that that the study protocol is an umbrella protocol. The drug is administered subcutaneously and the researchers aim to recruit 80 participants in this trial. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried how long the first phase of the study takes. The researchers explained that the first phase takes 29 days. The first three days are in-house and there are 6 follow up visits up to the 29th day endpoint.
The Chair opened the meeting at 1pm and welcomed Committee members, noting that apologies had been received from Dr Catherin Jackson. The noted that Ms Toni Millar was attending in an observational capacity and was not reviewing applications. The Chair noted that the meeting was quorate. The Committee noted and agreed the agenda for the meeting. Confirmation of previous minutes The minutes of the meeting of 11 October were confirmed. New applications 1 Ethics ref: 16/NTA/188 A study of RO7062931 in healthy subjects and patients chronically infected with hepatitis B virus infection Principal Investigator: Professor Ed Gane Sponsor: Covance NZ Ltd Clock Start Date: 03 November 2016 Dr Paul Hamilton and Ms Mary Ellis-Peglar were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The study is a phase I clinical trial of the study drug, RO7062931, to test its’ safety and tolerability in human subjects. The Committee noted that that the study protocol is an umbrella protocol. The drug is administered subcutaneously and the researchers aim to recruit 80 participants in this trial. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried how long the first phase of the study takes. The researchers explained that the first phase takes 29 days. The first three days are in-house and there are 6 follow up visits up to the 29th day endpoint.
nta-15-nov-2016-meeting-minutes.docx