A Phase 1, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Doses in Chronic Hepatitis B subjects - Trial ANZCTR12623000997651

Timeline & Enrollment

Primary Outcome

Safety and tolerability of multiple doses of DF-006 in CHB patients will be assessed by collecting adverse events and monitoring lab results (hematology, biochemistry, coagulation and serum chemokine/cytokine), ECGs, and vital signs. Adverse events will be initially reported based on subject reported events. These events will eventually be coded using MedDRA codes.

Summary

Drug Farm is developing an investigational drug called DF-006, for treatment of Chronic Hepatitis B. DF-006 is a drug that attaches to a protein in the cell known as Alpha-1 kinase (ALPK1). In the liver, upon attaching to ALPK1, there is an activation of the body’s immune system that leads to the expression of many immune-related proteins known as chemokines and cytokines. These chemokines and cytokines are thought to play a role at various stages of hepatitis B virus (HBV) lifecycle, ultimately leading to reductions in viral (1) replication, (2) immunosuppressive proteins and, (3) genetic material. The study has three main aims: • To see if DF-006 is safe and well-tolerated in subjects with chronic hepatitis B • To measure levels of DF-006, and compounds related to DF-006, in the blood over time, following multiple doses of DF-006. • To assess the anti-viral effects of DF-006 subjects with chronic hepatitis B The study will also look at: • Whether or not ethnicity affects the levels of DF-006 in the blood. • Whether DF-006 is processed and cleared differently in people of Asian ethnicity. • If certain markers in the blood show that DF-006 is working as predicted.

ICD-10 Classifications