DRKS00006087已完成2 期
Clinical study to investigate safety, tolerability, efficacy,pharmacokinetics and pharmacodynamics of inhaled multiple doses of the human GATA-3-specific DNAzyme solution SB010 in patients with moderate to severe COPD– A randomised, double-blind, parallel group, multicenter, phase IIa pilot study – - SB010-COPD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 one（—）
- 性别
- All
入选标准
- •Adult male and female Caucasian patients aged = 40.
- •2. Clinical diagnosis of moderate to severe, stable COPD, defined as a postbronchodilator Forced Expiratory Volume in One Second (FEV1) greater than 30 % of the predicted normal value and less than 80 % of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7.
- •3. Patients on stable COPD medication at least 4 weeks prior to screening
- •4. Sputum eosinophils = 2.5% at screening.
- •5. Current or ex-smoker with a smoking history of = 10 packyears
- •6. Ability to inhale in an appropriate manner (patients will be trained to inhale from the AKITA2 APIXNEB® device with a placebo medication at the screening visit)
- •7. Only men who do not want to father children for six months after the last dose of SB010
- •8. Only women who don’t plan pregnancy for six months after the last dose of SB010
- •9. WOCBP must use a double barrier method of contraception during the study and for 6 months following the last dose of study medication. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).
- •10. Male subjects whose sexual partners are WOCBP must use a double barrier method of contraception, one of which includes a condom, during the study and for 6 months after the end of treatment.
- •11. Patient is able to understand and give written informed consent
- •12. Provision of a written informed consent on participation in the trial prior to trial start and any trial-related procedures
排除标准
- •1. Presence of clinically significant diseases other than COPD and known COPD comorbidities (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may put the patient at risk because of participation in the trial
- •2. Diseases which may influence the results of the study or the patient’s ability to take part in it
- •3. Presence of relevant pulmonary diseases or history of thoracic surgery, such as:
- •- known active tuberculosis,
- •- history of interstitial lung or pulmonary thromboembolic disease,
- •- pulmonary resection during the past 12 months,
- •- history of asthma
- •- history of bronchiectasis secondary to respiratory diseases (e.g. cystic fibrosis, Kartagener’s syndrome, etc.),
- •- history of allergic bronchopulmonary aspergillosis or respiratory infection within the 4 preceding weeks of the first morning IMP administration
- •4. Clinically relevant acute infections in the last 4 weeks prior to randomization
- •5. Clinically relevant chronic infections
- •6. known clinically relevant allergies or idiosyncrasy to oligonucleotide based drugs
- •7. History of allergic reactions to any active or inactive ingredients of the nebulizer solution
- •8. Proneness to orthostatic dysregulation, faintings, or blackouts
- •9. History of malignancy within the past 5 years, except excised basaliomas
- •10. Clinically relevant abnormalities (except of known COPD / comorbidity related abnormalities) in clinical chemical, haematological or in any other laboratory variables as judged by the investigator
- •11. Positive results in any of the virology tests of acute or chronic infectious human immunodeficiency virus (HIV) and hepatitis B/C virus infections
- •12. Positive drug screen
- •13. Abuse of alcohol or drugs
- •14. Treatment with any known enzyme inducing or inhibiting agents (St. John's Wort (Johanniskraut), barbiturates, phenothiazines, cimetidine, ketoconazole etc.) within 30 days before first administration of trial medication or during treatment period of the trial
- •15. Treatment with any biologicals within three months before first administration of trial medication or during treatment period of the trial (only allowed by judgement of principal investigator)
- •16. Surgery of the gastrointestinal tract which may interfere with drug absorption of swallowed fraction (Note: this is not applicable for minor abdominal surgery such as appendectomy or herniotomy),
- •17. Planned lung transplantation
- •18. Blood donation within the last 30 days before screening
- •19. Planned donation of germ cells, blood, organs or bone marrow during the course of the trial or within 6 months thereafter
- •20. Participation in another clinical trial with an investigational drug or device within the last month or within 10 times the half-life of the respective drug. For biologics the minimum period is 10 times the half-life of the respective drug before inclusion in this trial
- •21. Lack of ability or willingness to give informed consent or inability to cooperate adequately
- •22. Anticipated non-availability for trial visits/procedures
- •23. Vulnerable subjects (e.g., persons kept in detention)
- •24. Employee at the investigational site, relative or spouse of the investigator.
- •25. Pregnancy or breast feeding
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