Phase 1/2 study of IMC-I109V in non-cirrhotic HBeAg-negative chronic hepatitis B (HBV) infection

The purpose of this study is to test IMCI109V in people with chronic hepatitis B virus (HBV) infection and to assess the safety and effectiveness a new treatment, called IMC-I109V. IMC- I109V has been developed to treat HBV by activating the body’s own immune system to fight the virus. This is the first time that IMC-I109V is being tested in humans. The study consists of 2 parts as follows; Part 1 – Single Ascending Dose (SAD): will be approximately 10 weeks for each participant, comprising a maximum 42-day screening period, a 1-day treatment period involving a single administration of IMC-I109V (by intravenous (IV) infusion) and a 28 day follow-up period, for a total of 9 visits. The first cohort will receive a single IMC-I109V starting dose of 0.8 mcg, and subsequent cohorts up to 60.0 mcg. Visits will take place on Day -1 and Days 1, 2, 3, 5, 8, 15, 22, and 29. Follow up may be extended in participants who achieve a decrease in HBsAg of greater than 0.5 log10 IU/mL at Day 29. Approximately 5 to 9 cohorts will be enrolled. Part 2 – Multiple Ascending Dose (MAD): will be approximately 54 weeks for each participant, comprising a maximum 42-day screening period, a 24-week treatment period involving weekly administration of IMC-I109V (by intravenous (IV) infusion), and a 24-week follow-up period, with a total of 30 visits. The initial dose in Part 2 – MAD will be the lowest dose evaluated during Part 1 – SAD i.e. 0.8 mcg. Visits will take place on Day -1 and Days 1, 3, 5, and 8, Weeks 3 (Day 15) through 24, Weeks 28, 36, 48 and 49. Participants who have achieved HBsAg less than 100 IU/mL at end of Week 24 may be considered for further study treatments of up to Week 48 and follow-up visits every 12 weeks to Week 72. Treatment will be discontinued at Week 16 in participants who have not shown evidence of a response to IMC-I109V. Approximately 3 to 6 dose cohorts will be enrolled and the maximum possible dose that may be administered to a cohort will be 60.0 mcg. The participant groups in SAD and MAD are exclusive.