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

NCT01403792 | Completed Phase 1

• 1 other identifier: CRC282
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus; Neutralising monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Occurrence, intensity and relationship to P2G12 administration of local and general adverse events (AEs) throughout the study period after drug administration.

  35 days.

Secondary Outcomes (1)

• Changes in levels of P2G12 in blood and vaginal secretions as compared to baseline.

  35 days

Study Arms (4)

Up to 7mg P2G12

EXPERIMENTAL

Drug: P2G12

Up to 14mg P2G12

EXPERIMENTAL

Drug: P2G12

Up to 28mg P2G12

EXPERIMENTAL

Drug: P2G12

Placebo (saline solution)

PLACEBO COMPARATOR

Drug: P2G12

Interventions

P2G12 DRUG

A single intravaginal administration of 1ml P2G12/placebo.

Placebo (saline solution); Up to 14mg P2G12; Up to 28mg P2G12; Up to 7mg P2G12

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Surrey: lead
• European Commission: collaborator

Study Sites (1)

Surrey Clinical Research Centre

Guildford, Surrey, GU2 7XP, United Kingdom

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Hubert A Bland, MBChB

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

GB (1)