Status:
COMPLETED
A Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
Lead Sponsor:
University of Surrey
Collaborating Sponsors:
European Commission
Conditions:
Human Immunodeficiency Virus
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of intravaginal administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1 will receive up to 7mg of ...
Detailed Description
This is a phase I study in healthy women aged 18 to 50 years, which involves vaginal application of study drug P2G12 or placebo. P2G12 is a monoclonal antibody (MAb) (a kind of protein), and belongs ...
Eligibility Criteria
Inclusion
- A female adult subject aged between 18 and 50 years old.
- They are in good health as determined by medical history, physical examination and clinical judgement before entering into the study.
- Subjects must agree to abstain from vaginal sexual intercourse for 72 hours before and after dosing.
- Subject must agree not to undertake any vaginal practices during study participation other than receptive intercourse with a male, or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
- Confirmation from the subject's GP that there is nothing in the subject's medical history that would prevent the subject from participating in the study.
Exclusion
- They have a known or suspected ongoing vaginal disease, malignancy or abnormality (including non-menstrual vaginal discharge) discovered at time of screening.
- They have an abnormality, or non-menstrual discharge noted at screening colposcopy.
- They present in the samples obtained at the screening visit:
- positive results for HIV 1 or 2 antibody.
- positive results for Hepatitis B sAg, anti-Hepatitis C antibody
- positive syphilis serology
- positive test for Neisseria gonorrhoea or Chlamydia trachomatis on urine or urethral swab sample
- abnormal cervical smear cytology
- A clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick.
- They have received any form of immunosuppressive or immunomodulatory (e.g. vaccines) therapy in the past 6 months.
- They are receiving any medications via vaginal route.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01403792
Start Date
June 1 2011
End Date
November 1 2011
Last Update
December 22 2011
Active Locations (1)
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1
Surrey Clinical Research Centre
Guildford, Surrey, United Kingdom, GU2 7XP