ACTRN12623001260617尚未招募1 期
A Phase 1 randomised, double blind, placebo-controlled study of the safety and immune response to GPV381 in otherwise healthy adults with detectable Porphyromonas gingivalis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
- •- Are male or female 40-60 years of age.
- •- Have detectable P. gingivalis in saliva at Screening
- •- Have an area on the upper arm that will allow adequate observation of any injection site reactions.
- •- Agree to practice effective contraception during the study period.
排除标准
- •- Are pregnant, breast feeding, or plan to become pregnant during the study period.
- •- Have had treatment with any other investigational therapy within 30 days or within 5 half-lives of that investigational therapy, whichever is longer, prior to Day 1.
- •- Have had treatment with antibiotics within one month of commencement on trial or expect to require antibiotic treatment during the trial.
- •- Have a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV).
- •- Have clinically significant gingivitis or periodontal disease or are undergoing a current treatment plan for these.
- •- Full or partial dentures, or dental implants.
- •- Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function
- •- Have clinically significant laboratory values at Screening, as assessed by an investigator.
- •- Have donated blood or blood-derived products (plasma) within 30 days or received blood or blood-derived products (plasma) within 90 days prior to Day 1 or plans to donate or use blood or blood products during the course of the study.
- •- Have any other medical condition or significant co-morbidities, clinically relevant social or psychiatric conditions, or any finding during Screening or on Day 1, which in the investigator’s opinion may increase the risk associated with study participation or interfere with the participant’s ability to comply with study procedures.
研究者
相似试验
进行中（未招募）
1 期
A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's diseaseCrohn's disease in young personsMedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2014-005666-29-GB4D Pharma18
已完成
1 期
An interventional study to evaluate the safety and immune response of a vaccine against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2, the virus that causes COVID-19 infection) when given to healthy adult participantsISRCTN51232965niversity of Queensland216
已完成
1 期
A phase I study into the safety, tolerability, pharmacokinetics and immunogenicity of PolyCAb in healthy subjectsSevere Clostridium difficile Infection (CDI)Infections and InfestationsISRCTN80902301MicroPharm Limited18
已完成
不适用
A phase 1 randomized, double-blind, placebo-controlled, maximum tolerated dose escalation, safety, tolerability and pharmacokinetic adaptive study of RAD1901 administered to healthy postmenopausal womebrain metastasis10027656breast cancer10006232NL-OMON41865Radius Health, Inc.68
招募中
1 期
A Phase 1 Study of AP02 (Nintedanib Solution for Inhalation) Delivered via the PARI eFlow® Nebulizer System to Evaluate the Safety, Tolerability, and Pharmacokinetics of AP02 in Healthy Volunteers (AP02-002)Respiratory - Other respiratory disorders / diseasesIdiopathic Pulmonary FibrosisACTRN12624000825550Avalyn Pharma, Inc.68