A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA

• Status: Unknown status
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, positive-control, dose-escalation Phase 1b trial in 60 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration over 28 days of multiple oral doses in a fasted state at the following planned dose levels: 200, 400, and then 600 mg.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Chronic Hepatitis B infection, defined as positive test for Hepatitis B surface antigen (HBsAg) for more than 6 months prior to randomization

• HBV DNA at screening greater than or equal to (>/=) 2 × 10^4 international units per milliliter (IU/mL) for Hepatitis B e antigen (HBeAg) positive participants, or >/=2 × 10^3 IU/mL for HBeAg-negative participants

• ALT> 1 x upper limit of normal (ULN) and < 10 x upper limit of normal (ULN)

• Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥4 weeks prior to screening are also eligible.

• Signed informed consent.

Exclusion Criteria:

• Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)

• Presence of autoimmune disorders

• History of liver disease other than Hepatitis B

• History of Gilbert's Disease

• Any sign of decompensated liver disease

• Known or suspected cirrhosis

• Evidence of hepatocellular carcinoma

• Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)

• Pregnant or lactating females

• Diabetes

• Alcohol or substance abuse

• History of bleeding diathesis

• Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator.

• History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease.