NCT07708116招募中1 期
A Phase 1 First-In-Human, Double-Blind, Single and Multiple Ascending Dose Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenous Doses of CTX-187 in Healthy Volunteers Followed by Multiple Doses in Patients With a Bacterial Infection
Centauri Therapeutics Limited1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2026年6月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this trial is to assess the safety and tolerability of single and multiple ascending intravenously (IV) infused doses of CTX-187 when administered to healthy adult male and female participants and participants with a bacterial infection (bronchiectasis participants chronically infected with P. aeruginosa).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Parts A and B: Healthy adult males and/or females, 18 to 65 years of age.
- •Parts A and B: Body mass index (BMI): ≥18.0 and ≤32.0 kg/m^2 and weight >50 kg.
- •Parts A and B: Good physical and mental health without clinically significant abnormalities.
- •Part C: Adult males and/or females, 18 to 75 years of age.
- •Part C: Prior clinical and computerized tomography diagnosis of bronchiectasis.
- •Part C: P. aeruginosa in sputum, bronchoalveolar lavage or another airway sample at least once in the 12 months prior to screening and P. aeruginosa in sputum during screening, both of which should be at least 21 days apart.
- •Part C: Otherwise in good physical and mental health without clinically significant abnormalities.
排除标准
- •Parts A and B: Previous participation in the current trial.
- •Parts A and B: History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant.
- •Parts A and B: Participation in a drug trial within the previous 30 days before the first dose of trial drug or 5x elimination half-life, if known, whichever is longer.
- •Part C: Known hypersensitivity to any reagents contained in CTX-187 or documented hypersensitivity reaction or anaphylaxis to any medication.
- •Parts A, B and C: Known clinical diagnosis of cystic fibrosis, active allergic bronchopulmonary aspergillosis or active tuberculosis or nontuberculous mycobacterial infection; primary diagnosis of asthma or chronic obstructive pulmonary disease.
- •Part C: Treatment with long term inhaled, systemic or nebulized anti-pseudomonal antibiotics which are newly initiated within the previous 3 months prior to screening.
- •Part C: Receipt of anti-pseudomonal antibiotics for an exacerbation during the screening period.
- •Part C: History or presence of unstable co-morbidities: cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant. Participants on stable doses of anti-hypertensive medications or statins may be included following discussion between the Investigator and the medical monitor.
- •Part C: History of known or suspected Clostridioides difficile infection or diarrhoea within one week of recruitment, not resolved during the past 5 days.
- •Part C: Participants with an acute exacerbation of bronchiectasis.
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to Day 28
TEAEs include clinically significant abnormalities in electrocardiograms (ECGs), vital signs, clinical laboratory values and physical examination.
次要结局
- Number of Participants with Antidrug Antibodies (ADA) Against CTX-187 in Serum(Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9)
- Area Under the Concentration-time Curve (AUC) of CTX-187 in Plasma(Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9)
- Maximum Observed Plasma Concentration (Cmax) of CTX-187(Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9)
- Time to Attain Maximum Observed Plasma Concentration (tmax) of CTX-187(Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9)
- Terminal Elimination Half-life (t1/2) of CTX-187 in Plasma(Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9)
- Clearance (CL) of CTX-187(Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9)
- Volume of Distribution at Steady-state (Vss) of CTX-187(Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9)
研究者
研究点 (1)
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