ACTRN12622000392763招募中1 期
A Phase 1 Single and Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of SZN-043, a Novel Bispecific Fusion Protein Targeting ASGR1 and ZNRF3/RNF43, in Healthy Volunteers and Subjects with Liver Cirrhosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female volunteers.
- •1. Males or female with documented history of liver cirrhosis and a Child-Pugh score between 5 and 7, inclusive, at screening.
- •2.A fibroscan of equal to or greater than 6kPa.
- •3.MELD Score of equal to or less than 12 at Screening based on local lab results.
排除标准
- •Part 1 (Healthy Volunteers)
- •1.Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
- •2.Previous receipt of antibody or biologic therapy whether licensed or investigational (immunoglobulin products, monoclonal antibodies or antibody fragments) within the past 6 months.
- •3.History of hyperthyroidism, Paget’s disease, osteomalacia, or fracture within 4 weeks of Screening.
- •4.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 prior to study drug administration.
- •5.Regular excessive alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint ~240 mL of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- •6.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. Subjects under evaluation for possible malignancy are not eligible.
- •Part 2: Subjects with Liver Cirrhosis
- •1.Cirrhosis from biliary aetiology.
- •2.Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
- •3.Previous receipt of antibody or biologic therapy whether licensed or investigational (immunoglobulin products, monoclonal antibodies or antibody fragments) within the past 6 months.
- •4.History of hyperthyroidism, Paget’s disease, osteomalacia, or fracture within 4 weeks of Screening.
- •5.Use of controlled substances (including inhaled or injected drugs), or non-prescribed use of prescription drugs within previous 12 months.
- •6.History of alcohol consumption within 3 months prior to Screening for subjects with cirrhosis due to alcoholic liver disease.
- •7A 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.
- •8.Hepatic mass(es) evident on liver imaging (ultrasound) at Screening.
- •9.Previous liver transplantation.
- •10.Active or recent (within 14 days of Screening) gastrointestinal bleeding.
- •11.Subjects with portal vein thrombosis.
- •12.Subjects with a portosystemic shunt or scheduled for transjugular intrahepatic portosystemic shunt (TIPS) placement during the study period.
- •13.Requirement for renal replacement therapy.
- •14.Current use of anticoagulants that affect prothrombin time or international normalised ratio.
- •15.Extensive resection of large segments of small intestine (short gut) or severe gastroparesis.
研究者
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