A Phase II, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Asthmatic Subjects Subsequently Challenged With Human Rhinovirus (HRV-16)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Hvivo
- 入组人数
- 60
- 主要终点
- Primary Efficacy Endpoint: The Area Under the Curve (AUC) of total symptom score post viral challenge.
研究概览
简要总结
Phase 2 study, to examine the prophylactic efficacy, safety and tolerability of PrEP-001 in asthmatics who have been infected with the human rhinovirus (HRV16) after receiving two doses of the study drug/placebo.
详细描述
Screening took place up to 90 days before quarantine, where volunteers were asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.
Eligible volunteers were invited to test and record their respiratory symptoms and peak expiratory flow (PEF), medications and any adverse events in diary cards from Day -14 to Day -5.
They attended Quarantine on Day -4/-3, received the study drug/placebo intra nasally on Day -2 and Day -1 and subsequently challenged with HRV16 on Day 0. Randomisation to receive study drug/placebo was 1:1.
Volunteers remained in the quarantine unit for 8 days after inoculation.
PEF self-testing continued from Day 9 to Day 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 55 years on the day of first dosing with IMP.
- •Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage
- •In good health with no history of major medical conditions (other than asthma) that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.
排除标准
- •Any ex-smoker or smoker with a history of more than 10 pack-years.
- •History of life-threatening asthma, Diagnosis of COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
- •Any history or evidence of any clinically significant medical and psychiatric conditions
研究组 & 干预措施
IMP - PrEP-001
In Viral Challenge arm cohort:
A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).
In the Safety arm's first dose cohort:
A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).
Then assuming no significant safety issues with the lower dose (as determined by blinded review by the DSMB team), the Safety arm's second dose cohort will consist of:
A nasal dose of 12800 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1)
干预措施: PrEP-001 (Drug)
Placebo - G-004
In the Viral Challenge arm and each Safety Arm cohort:
A nasal dose of placebo equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).
干预措施: G-004 (Drug)
结局指标
主要结局
Primary Efficacy Endpoint: The Area Under the Curve (AUC) of total symptom score post viral challenge.
时间窗: Day -14 to Day 28
AUC of total symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). Total symptom scores (from the symptom diary card) used to calculate the AUC. The primary endpoint is only being derived from the Viral Challenge arm.
次要结局
- Secondary Efficacy Endpoint: Symptom Scores: Area Under the Curve (AUC)(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Symptom Scores: Time to resolution from peak symptoms(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: viral shedding(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: incidence of laboratory-confirmed Influenza illness(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: laboratory confirmed Influenza A/Perth/16/2009 (H3N2) Virus infection(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: HRV-like-illness(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Sub-clinical infection(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Upper respiratory tract illness(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Lower respiratory tract illness(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Febrile illness(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Systemic illness(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Non-sick and uninfected(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Viral replication, as measured by tissue culture assay(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Incidence(s) of illness and infection: Seroconversion(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Viral Load Parameters: Area under the curve (AUC) of viral load, as measured by nasopharyngeal swab RT-qPCR(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash RT-qPCR(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash RT-qPCR(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Viral Load Parameters: Time to peak viral shedding, as measured by nasal wash RT-qPCR(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Time to resolution from peak viral shedding, as measured by nasal wash RT-qPCR.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Area under the curve (AUC) of viral load, as measured by nasal wash TCID50.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Duration of virus shedding, as measured by nasal wash TCID50.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Peak virus shedding, as measured by nasal wash TCID50.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Time to peak viral shedding, as measured by nasal wash TCID50.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Change in Asthma Control Questionnaire (ACQ) score compared to pre-Challenge.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Change in Fractional exhaled nitric oxide (FeNO) compared to pre-Challenge.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Total weight of nasal discharge produced post Viral Challenge to Quarantine discharge.(Day -4 to Day 28)
- Secondary Efficacy Endpoint: Change in lung function compared to pre-Challenge.(Day -4 to Day 28)