A Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

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 P2G12, or placebo. Three subjects in Group 2 will receive up to 14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical inspections will be performed to determine what effect, if any, the study drug has had on the site of administration. Adverse event data will be collected throughout the trial.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Surrey
• Collaborator: European Commission
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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:

1. positive results for HIV 1 or 2 antibody.

2. positive results for Hepatitis B sAg, anti-Hepatitis C antibody

3. positive syphilis serology

4. positive test for Neisseria gonorrhoea or Chlamydia trachomatis on urine or urethral swab sample

5. 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.