ACTRN12624000194561招募中1 期
A Phase 1b Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of SZN-043 in Participants with Severe Alcohol-Associated Hepatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. 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. BMI between 18.0 and 36.0 kg/m2, inclusive, at Screening.
- •3. A clinical diagnosis of AH that is anticipated to require inpatient care for a period to encompass at a minimum the first dose of study drug based on typical serum chemistry (as determined by local laboratory) meeting all of the following parameters:
- •a. Onset of jaundice within prior 8 weeks;
- •b. History of heavy alcohol abuse: >40 (female) or 60 (male) g alcohol/day for greater than or equal to 6 months;
- •c. Consumed alcohol within 8 weeks before study entry;
- •d. AST >50, AST/ALT >1.5, and both values are: <400 IU/L, and
- •e. Serum total bilirubin >3.0 mg/dL.
- •4. MELD score of 21 to 30, inclusive.
- •5. Willing to use acceptable methods of contraception or not physically able to conceive or impregnate others.
排除标准
- •1. Previous receipt of antibody or biologic therapy 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
- •4. Recent start of liver toxic medications
- •5. Have a portosystemic shunt or scheduled for transjugular intrahepatic portosystemic shunt placement or highly likely to receive a liver transplant during the study.
- •6. Dependent upon inotropic support (including selepressin or terlipressin) or ventilatory or vasopressor support.
- •7. Organ failure (as defined by hepatic encephalopathy >stage 3) or requires renal replacement therapy or creatinine >2.5 mg/dL (or 221 mmol/L).
- •8. Uncontrolled hyperthyroidism, history of Paget's disease, osteomalacia, or fracture within 4 weeks of Screening.
- •9. Uncontrolled bacterial infections, as determined by the investigator's judgment 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, evidence of recurrence of certain skin cancers, or under investigation for a malignancy.
- •13. Gastrointestinal (GI) bleeding within 2 days of Screening requiring transfusion of more than 3 units of blood.
- •14. Grade 3 or higher encephalopathy by West Haven Criteria.
- •15. Acute kidney injury defined as an increase in serum creatinine (sCr) greater than or equal to 0.3 mg/dL within 48 h or increase in sCr greater than or equal to 50% from baseline known or presumed
- •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 non-prescribed opiates.
- •24. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
- •25. Planning to donate sperm (male) or ovum (female) within 90 days after the last dose of study drug.
- •26. Current use of anticoagulants that affect prothrombin time or international normalised ratio (INR).
- •27. Eligibility: All participants where HepQuant SHUNT test kit use is specified:
- •a. Extensive resection of large segments of small intestine (short gut) or severe
- •gastroparesis; On either a non-selective beta blocker or an angiotensin-converting
- •enzyme inhibitor or angiotensin II receptor blockers who are unwilling or unable
- •to delay taking their normal dose the morning of the HepQuant SHUNT test;
- •b. Allergy to any ingredient in the formulations or components in the HepQuant Lab
- •Developed kit.
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