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

NCT ID: NCT03770624

Last Updated: 2018-12-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2019-04-30

Brief 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.

Detailed Description

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.

Conditions

Chronic Hepatitis b

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

200 mg QD

Tablet QL-007 will be administered orally daily (200 mg QD) over the 28 days under fasted state. Patients fast for 10h before administration and 1h after administration.

Group Type: EXPERIMENTAL

QL-007 tablet

Intervention Type: DRUG

QL-007 will be administered orally daily over the 28 days under fasted state.

400 mg QD

Tablet QL-007 will be administered orally daily (400 mg QD) over the 28 days under fasted state. Patients fast for 10h before administration and 1h after administration.

Group Type: EXPERIMENTAL

QL-007 tablet

Intervention Type: DRUG

QL-007 will be administered orally daily over the 28 days under fasted state.

600 mg QD

Tablet QL-007 will be administered orally daily (600 mg QD) over the 28 days under fasted state. Patients fast for 10h before administration and 1h after administration.

Group Type: EXPERIMENTAL

QL-007 tablet

Intervention Type: DRUG

QL-007 will be administered orally daily over the 28 days under fasted state.

100 mg BID

Tablet QL-007 will be administered orally daily (100 mg BID) over the 28 days under fasted state. Patients fast for 2h before administration and 1h after administration.

Group Type: EXPERIMENTAL

QL-007 tablet

Intervention Type: DRUG

QL-007 will be administered orally daily over the 28 days under fasted state.

200 mg BID

Tablet QL-007 will be administered orally daily (200 mg BID) over the 28 days under fasted state. Patients fast for 2h before administration and 1h after administration.

Group Type: EXPERIMENTAL

QL-007 tablet

Intervention Type: DRUG

QL-007 will be administered orally daily over the 28 days under fasted state.

TDF 300 mg QD

TDF will be administered orally daily (300 mg QD) over the 28 days not request fast .

Group Type: ACTIVE_COMPARATOR

TDF

Intervention Type: DRUG

TDF will be administered orally daily over the 28 days e.

Interventions

QL-007 tablet

QL-007 will be administered orally daily over the 28 days under fasted state.

Intervention Type: DRUG

TDF

TDF will be administered orally daily over the 28 days e.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Guiqiang Wang, Dr

Role: primary

Other Identifiers

QL-007-003

Identifier Type: -

Identifier Source: org_study_id