A Phase I Safety Study Of A Single Vaginal Administration Of P2G12

• Research type

  Research Study

• Full title

  A Double-Blind, Placebo-Controlled, Randomised, Dose-Escalation Phase I Safety Study Of A Single Vaginal Administration of P2G12 Antibody In Healthy Female Subjects.

• IRAS ID

  31429

• Contact name

  Hubert Bland

• Eudract number

  2009-015609-38

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase I study in healthy women aged 18 to 45 years, which involves vaginal application of study drug P2G12 or placebo.P2G12 is a monoclonal antibody (MAb) (a kind of protein), and belongs to a group of MAbs that can help to prevent and protect from HIV infection. Most of these MAbs have been produced using a system called Chinese Hamster Ovary cell (CHO-Cell) fermentation, e.g. C2G12. This method of production is very expensive and cannot produce enough MAbs on a scale required for the global market. Unlike C2G12, P2G12 is manufactured from plants. It is hoped that Plant manufacture of such MAbs may offer some solutions to the high cost and low output of CHO-cell fermentation. This study is designed to confirm the safety of a vaginally delivered MAb (P2G12) derived from plants and manufactured to Good Manufacturing Practice (a quality standard used for the maunfacture of medicinal products). 11 subjects will be enrolled consecutively in cohorts (groups); in each successive cohort a higher dose of study drug will be administered, as well as placebo. The dose range is 6.25 to 25mg of P2G12 in saline. The study will take place at one UK centre. Subjects attend 7 visits over 13 weeks. At visit 3 subjects receive a single administration of study drug/placebo. Study visits include the following procedures: physical exam, vital signs, blood and urine samples, cervical smear test and colposcopy (medical examination of the cervix). The relationship of adverse events (AEs) and serious adverse events (SAEs) to P2G12 administration, and abnormal laboratory test results as compared to baseline (pre-dose) values, will determine the safety of P2G12 in the study. Levels of P2G12 in serum and vaginal samples will be measured at particular time-points in order to understand how quickly P2G12 is broken down by the body (pharmacokinetics).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  09/H0717/83

• Date of REC Opinion

  1 Apr 2010

• REC opinion

  Further Information Favourable Opinion