2024-518102-41-00已完成2 期
A phase II trial to assess the activity and tolerability of Thymosin alpha 1 in Cystic Fibrosis Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The activity of Thymosin alpha 1 will be evaluated by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in sputum.
研究概览
简要总结
The evaluation of the activity of Thymosin alpha 1 in patients with cystic fibrosis (CF) by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in sputum.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, from 18 years of age (inclusive) at the time of screening.
- •Blood pressure: DBP values between 60 and 89 mmHg, and SBP values between 90 and 139 mmHg. ECG normal or wave changes not considered clinically significant.
- •Pulse betweem 50 and 120 bpm unless deemed clinically. insignificant by the PI.
- •Signed Informed Consent.
- •Confirmed diagnosis of CF, based on the following: two sweat chloride tests with a result = 60 mEq/L or two CFTR mutations on genetic test.
- •CF diagnosis independently of genetic mutations.
- •Clinical stability with no change in symptoms and/or medication within 4 weeks prior to screening.
- •Body mass index (BMI) = 15.0 (kg/m2).
- •Non-tobacco/nicotine-containing product user for a minimum of 6 months prior to screening.
- •Percent Predicted Forced Expiratory Volume (ppFEV1) > 40%, predicted at screening.
- •Female with pregnancy test negative and using an acceptable contraception method, except if postmenopausal for more than 2 years or sterilized for more than 3 months.
排除标准
- •Clinical/laboratory/radiological/spirometric signs of unstable or unexpectedly deteriorating respiratory disease (30 days prior to the screening).
- •In the judgment of the PI, clinically significant hemoptysis (>30 ml per episode) within the last 180 days.
- •History of allergy, hypersensitivity, intolerance to Thymosin alpha1 and to its excipients (Mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate)
- •Ongoing or prior participation in an investigational drug study within 30 days of screening.
- •Any malignancy or chronic organ failure or disease that depart from the patient's usual baseline level of health as a patient with CF.
- •Patients with “F508del homozygous mutation” treated successfully with corrector potentiators, according to physicians’ judgment.
- •Intravenous antibiotic use in the last 4 weeks before screening.
- •Treatment with oxygen.
- •History of organ or hematological transplantation.
- •Kidney (creatinine 2-fold of the normal upper limit) or hepatic alterations (Child Pugh score equal to B or C).
- •History or presence of alcoholism or drug abuse within 2 years prior to the screening.
- •Personal or family history of prolonged QT syndrome; or a QTc interval >430 msec (males) or > 450 msec (females) using Bazett's formula (QTcB) or deemed clinically significant by the PI.
结局指标
主要结局
The activity of Thymosin alpha 1 will be evaluated by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in sputum.
The activity of Thymosin alpha 1 will be evaluated by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in sputum.
次要结局
- Safety and tolerability will be evaluated during the course of the study by means of: - Type, incidence, severity, timing, seriousness and relatedness of reported AEs. - Physical examinations. - Vital signs. - ECGs. - Clinical laboratory results (local lab).
- Activity will be evaluated during the course of the study by monitoring: - variation of a combined score of inflammatory cytokines; - variation of neutrophil elastase in sputum; - variation of blood C-reactive protein; - variation of the sweat chloride concentration tests.
- Efficacy will be evaluated by monitoring during the course of the study of: - change in predicted forced expiratory volume in 1 second (ppFEV1). - change in quality of life measured by CFQ-R questionnaire
研究者
Cevi Wang
Scientific
Sciclone Pharmaceuticals International (SG) Pte. Ltd.
研究点 (1)
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