NL-OMON50967已完成不适用
A randomized, controlled, partial-blind, parallel-group study evaluating the effect of oral administration of BAY 1834845 and BAY 1830839 twice daily for 7 consecutive days on local and systemic IRAK4 pathway-related challenges in healthy male participants - Mechanistic study of BAY·1834845 and BAY 1830839
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participant must be 18 to 55 years of age inclusive, at the time of signing
- •the informed consent.
- •2. Overtly healthy as determined by medical evaluation including medical and
- •surgical history, physical examination, laboratory tests, ECG and vital signs.
- •3. Participant has Fitzpatrick skin phototypes I (very fair), II (fair), or III
- •(darker white skin).
- •4. Body weight must be above 50 kg and body mass index (BMI) above or equal
- •18.5 and lower or equal 28 kg/m2 at the screening visit.
排除标准
- •1. Medical disorder, condition or history of such that would impair the
- •participant's ability to take part in or complete this study in the opinion of
- •the investigator
- •2. A history of relevant diseases of vital organs, of the central nervous
- •system including neuropsychiatric illness or other organs, previous syncope or
- •autoimmune disease such as multiple sclerosis, inflammatory bowel disease,
- •rheumatoid arthritis or other immune-inflammatory diseases.
- •3. Unintended weight loss or gain of at least 5 kg in 4 weeks at screening.
- •4. Any serious concomitant illness that anticipates the need of systemic
- •medication interfering with the study medication.
- •5. A history of trauma with likely damage to the spleen, surgery to spleen or
- •congenital abnormalities of the spleen.
- •6. Hemorrhagic diathesis (easy bruising, epistaxis, gastro-intestinal bleeding).
- •7. History of known pulmonary embolism or known anti-phospholipid syndrome.
- •8. Previous participation in an i.v./systemic LPS challenge trial or prior
- •exposure to endotoxin within one year before start of treatment.
- •9. Diseases for which it can be assumed that the absorption, distribution,
- •metabolism, elimination and effects of the study intervention(s) will not be
- •normal (cholecystectomy permitted).
- •10. Any infection requiring hospitalization, systemic antimicrobial therapy
- •within 60 days, or as otherwise judged to be an opportunistic infection or
- •clinically significant by the investigator, within the past 6 months prior to
- •treatment period.
- •11. Any active or ongoing chronic infectious disease including periodontitis
- •with the exception of common viral or fungal skin infections such as plantar
- •warts or athlete's foot.
- •12. Febrile illness within 30 days before the start of the first study
- •intervention.
- •13. Medical history of sepsis, tuberculosis, increased frequency of infections,
- •immunodeficiency diseases, with recent febrile diseases and anamnestic and/or
- •laboratory signs of an impaired immune status or latent infections (hepatitis
- •B, hepatitis C, and human immunodeficiency virus [HIV]).
- •14. History of COVID-19 within 6 months prior to treatment period or in case of
- •clinically relevant sequela of former COVID-19 (such as fatigue or exercise
- •15. Contact with SARS-CoV-2- positive or COVID-19 patient within the last 2
- •weeks prior to SARS-CoV-2 viral PCR test (at visit 2).
- •16. History of major surgery within 8 weeks prior to treatment period or
- •scheduled (elective) surgery, planned hospitalization and surgical dental
- •treatment within study and 4 weeks after final follow-up.
- •17. History of or acute atopic dermatitis with active eczematous lesions,
- •bronchial asthma or allergic rhino-conjunctivitis symptomatic during screening
- •18. History of other concomitant skin conditions (chronic inflammatory
- •dermatoses) that would interfere with the evaluation of the effect of the study
- •medication on contact dermatitis.
- •19. History of hypersensitivity to any of the components of the study
- •interventions.
- •20. History of malignant tumors (except treated basal cell carcinoma).
- •21. Any clinical contraindications to treatment with steroids, such as
- •uncontrolled hypertension, chronic liver disease (Child*Pugh scores B or C),
- •latent diabetes mellitus, history of gastrointestinal bleeding.
- 另有 1 项未显示
研究者
相似试验
进行中（未招募）
1 期
Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the pastRheumatoid ArthritisEUCTR2012-003876-38-PLHexal AG (a Sandoz company)100
进行中（未招募）
1 期
Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the pastRheumatoid ArthritisEUCTR2012-003876-38-HUHexal AG (a Sandoz company)100
进行中（未招募）
1 期
Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the pastRheumatoid ArthritisEUCTR2012-003876-38-DEHexal AG (a Sandoz company)100
已完成
2 期
A randomized, double-blinded, parallel-controlled, dose exploratory, multicentered-phase II clinical trial for the safety and effectiveness of hydroxysafflor yellow A (HSYA) injection in the treatment of&Acute atherosclerotic thrombotic cerebral infarctionITMCTR2000002982Guangdong Hospital of traditional Chinese Medicine
尚未招募
不适用
A randomized, double-blind, parallel-controlled, multicenter trial to evaluate the effectiveness and safety of Xiyanping injection combined with azithromycin and azithromycin in the treatment of mycoplasma pneumoniae pneumonia in childreMycoplasma pneumoniae pneumoniaITMCTR2000003093The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine