FuturePharma

• Research type

  Research Study

• Full title

  Phase I Dose escalation trial to evaluate the safety of single IV administration of P2G12 in healthy volunteers

• IRAS ID

  195966

• Contact name

  Catherine Cosgrove

• Contact email

  ccosgrov@sgul.ac.uk

• Sponsor organisation

  St Georges University of London

• Eudract number

  2016-001817-25

• Clinicaltrials.gov Identifier

  NCT02923999

• Duration of Study in the UK

  0 years, 11 months, 28 days

• Research summary

  Given the continuing world-wide epidemic of HIV, there is an urgent need to develop methods to prevent infection.
  
  The purpose of the study is to find out if it is safe to give the study drug, P2G12, to healthy volunteers.

  P2G12 is anti HIV monoclonal antibody (MAB)(a protein targeted to attack just HIV) and has previously been given to women as a liquid inserted into the vagina. It has not been given as an intravenous infusion to humans but similar products had been given previously alone or in combinations without any concerns. It is hoped that P2G12 could eventually be used to prevent and treat HIV infection.
  
  In this study, 18 healthy adult volunteers will be recruited to attend 8 scheduled clinic visits over 6 months. There will be three groups of 6 volunteers receiving increasing doses of the MAB.
  Upon voluntary consent, eligibility and fitness to participate will be assessed on the screening visit including medical and social history, physical examination, urine and blood tests.
  On the dosing visit, volunteers will receive a single intravenous infusion of P2G12 and they will be observed for six hours afterwards.
  Any changes in general health and medication occuring between the clinic visits, will be recorded in a diary card to help the study doctor to evaluate the potential effects of the infusion.
  There will be 6 post-infusion clinic visits scheduled for regular blood and urine tests to measure drug levels and normal laboratory parameters. Information from diary cards will also be collected.
  Detailed information about risks and benefits as well as the visit schedule will be provided prior to written consent. Volunteers will receive an inconvenience allowance for their time.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  17/LO/0093

• Date of REC Opinion

  10 Mar 2017

• REC opinion

  Further Information Favourable Opinion