ISRCTN55168173进行中（未招募）1 期
A Phase Ib study evaluating the safety and pharmacokinetics of SZN 043 in participants with severe alcohol-associated hepatitis
Surrozen0 个研究点目标入组 18 人开始时间: 2024年5月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- 性别
- All
入选标准
- •1. Be a male or female (sex assigned at birth), 18 years of age or older AND considered to be an adult in accordance with local law
- •2. Have a BMI between =18.0 and =36.0 kg/m2 at Screening
- •3. Be willing and able to provide written informed consent
- •4. Have a clinical diagnosis of Alcohol-associated hepatitis (AH) that is anticipated to require inpatient care for a period to encompass at a minimum the first dose of study medication based on typical serum chemistry (as determined by local laboratory) meeting all of the following parameters:
- •4.1. Onset of jaundice within the prior 8 weeks
- •4.2. History of heavy alcohol abuse: >40 (female) or 60 (male) g alcohol/day for =6 months
- •4.3. Consumed alcohol within 8 weeks before study entry
- •4.4. AST >50, AST/ALT >1.5, and both values are: <400 IU/L, and
- •4.5. Serum total bilirubin >3.0 mg/dL
- •At the Investigator's discretion, a liver biopsy may be performed to confirm diagnosis in participants who meet criteria a-c above but where other causes of liver disease are not otherwise possible to rule out (viral, drug, autoimmune, etc)
- •5. MELD score of 21 to 30, inclusive
- •6. Acceptable methods of contraception defined in protocol Section 4.2.3 must be used from Screening until study completion. Surgically sterile males or females (Section 4.2.3) or women who are postmenopausal for =12 months do not need additional contraception methods. Postmenopausal status will be confirmed by testing follicle-stimulating hormone (FSH) levels =40 IU/L at Screening for amenorrhoeic female participants.
- •7. Must have the ability and willingness to attend the necessary visits to the study centre.
排除标准
- •1. Previous receipt of antibody or biologic therapy whether licensed or investigational within the past 6 months.
- •2. Treatment with any experimental drug within 30 days, or within 5 half-lives (whichever is longer), before Day 0 visit (Baseline).
- •3. Other causes of liver disease including:
- •3.1. Evidence of chronic viral hepatitis (hepatitis B or C)
- •3.2. Biliary obstruction or cholestatic liver disease (e.g., primary biliary sclerosis, sclerosing cholangitis)
- •3.3. Drug-induced hepatotoxicity (e.g., acetaminophen)
- •3.4. Hepatocellular carcinoma
- •3.5. Wilson’s disease
- •3.6. Budd Chiari Syndrome
- •3.7. Metabolic dysfunction-associated steatotic liver disease
- •3.8. Metabolic dysfunction-associated steatohepatitis
- •3.9. Auto-immune hepatitis
- •3.10. Acute hepatitis A.
- •4. Introduction of a new medication with potential hepatotoxicity within 60 days of screening or any anticipated increase in dose or dose regimen of any potential hepatotoxic medication.
- •5. Have a portosystemic shunt or scheduled for transjugular intrahepatic portosystemic shunt placement or highly likely to receive a liver transplant during the study period.
- •6. Dependent upon inotropic support or ventilatory or vasopressor support.
- •7. Organ failure: renal replacement therapy or creatinine >2.5 mg/dL (or 221 mmol/L Uncontrolled hyperthyroidism, history of Paget's disease, osteomalacia, or fracture within 4 weeks of Screening.
- •9. Uncontrolled bacterial infections, after a minimum of 2 days of antibiotic therapy.
- •10. History of a previous severe allergic reaction with generalised urticaria, angioedema, or anaphylaxis.
- •11. A QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 msec for males and >470 msec for females based on either single or averaged QTcF values of triplicate ECGs before study drug administration.
- •12. A history of malignant neoplasm, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (>1 year ago) or carcinoma in situ of the uterine cervix (>3 years ago) that has been fully treated and shows no evidence of recurrence. Participants under evaluation for possible malignancy are also not eligible.
- •13. Gastrointestinal (GI) bleeding within 2 days of Screening requiring transfusion of more than 3 units of blood (participants with a recent upper gastrointestinal bleeding that is controlled for >48 h is allowed).
- •14. Grade 3 or higher encephalopathy by West Haven Criteria.
- •15. Acute kidney injury defined as an increase in serum creatinine (sCr) =0.3 mg/dL within 48 h or an increase in sCr =50% from baseline known or presumed (Baseline sCr: a value of sCr obtained in the previous 3 months, closest to admission; if no previous sCr value, the sCr on admission is baseline), within the prior 7 days or the requirement for renal replacement therapy.
- •16. Presence of portal vein thrombosis.
- •17. Presence of acute pancreatitis.
- •18. Cerebral hemorrhage, extensive retinal hemorrhage, acute myocardial infarction (within the last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation).
- •19. Evidence of GI bleeding or renal failure after 7 days of treatment within 8 weeks of screening.
- •20. Liver imaging at screening showing any lesions (except benign lesions, i.e., hemangiomas).
- •21. Known infection with HIV or HIV Ab positive at screening.
- •22. Organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant.
- •23. Positive urine screen for amphetamines, cocaine, or opia
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