A Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
A Double-Blind, Placebo-Controlled, Randomised, Dose-Escalation Phase I Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
調査の概要
詳細な説明
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 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 manufacture 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 from up to 7 to up to 28mg of P2G12 in saline.
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 vaginal and serum samples will be measured at particular time-points in order to understand how quickly P2G12 is broken down by the body (pharmacokinetics) and whether any P2G12 is absorbed into the systemic circulation.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Surrey
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Guildford、Surrey、イギリス、GU2 7XP
- Surrey Clinical Research Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Up to 7mg P2G12
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A single intravaginal administration of 1ml P2G12/placebo.
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実験的：Up to 14mg P2G12
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A single intravaginal administration of 1ml P2G12/placebo.
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実験的：Up to 28mg P2G12
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A single intravaginal administration of 1ml P2G12/placebo.
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プラセボコンパレーター：Placebo (saline solution)
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A single intravaginal administration of 1ml P2G12/placebo.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Occurrence, intensity and relationship to P2G12 administration of local and general adverse events (AEs) throughout the study period after drug administration.
時間枠：35 days.
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35 days.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Changes in levels of P2G12 in blood and vaginal secretions as compared to baseline.
時間枠：35 days
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35 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Hubert A Bland, MBChB、University of Surrey
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CRC282
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