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

Phase 1

Recruiting

• Conditions: Alcoholic Hepatitis; Liver Cirrhosis; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622000392763
• Lead Sponsor: Surrozen Operating, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-07
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Part 1:
1. Healthy male or female volunteers.

Part 2:
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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified