A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults With Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
详细描述
This is a single-centre, open-label, single arm, clinical trial in two sequential stages, with no stratification. 12 patients will be enrolled in Stage 1, and a further 12 patients will be enrolled in Stage 2 (total of 24 patients in the trial).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial procedures.
- •Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- •Newly diagnosed pulmonary TB.
- •Rifampicin susceptible pulmonary TB as determined by molecular testing.
- •Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more).
- •Spirometry performed during screening with a Forced Expiration Volume in the first second (FEV1) of ≥ 40%.
- •Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4.
排除标准
- •HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)
- •Baseline Methaemoglobin saturation (SpMet) >3%.
- •Female patients who is pregnant or breast-feeding.
- •Patients planning to conceive a child within the anticipated period of trial participation and for at least 90 days after the last dose of IMP in the trial.
- •Participation in other clinical studies with investigational agents within 8 weeks prior to screening.
- •Treatment received for this episode of TB with any drug active against M.tb
- •Treatment with immunosuppressive medications such as TNF-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening.
- •Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.
研究组 & 干预措施
RESP30TB + HRZE
Stage 2 - Inhaled RESP30TB 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily
干预措施: RESP30TB (Drug)
RESP30TB
Stage 1 - Inhaled RESP30TB 6ml via nebulisation three times daily
干预措施: RESP30TB (Drug)
RESP30TB + HRZE
Stage 2 - Inhaled RESP30TB 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily
干预措施: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination) (Drug)
结局指标
主要结局
Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: Dosing period 14 days + Follow-up period 14 days
Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death
次要结局
未报告次要终点