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

Qilu Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Chronic Hepatitis b

Treatments: Drug: TDF; Drug: QL-007 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03770624

QL-007-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

60 participants in 6 patient groups

200 mg QD

Experimental group

Description:

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.

Treatment:

Drug: QL-007 tablet

400 mg QD

Experimental group

Description:

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.

Treatment:

Drug: QL-007 tablet

600 mg QD

Experimental group

Description:

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.

Treatment:

Drug: QL-007 tablet

100 mg BID

Experimental group

Description:

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.

Treatment:

Drug: QL-007 tablet

200 mg BID

Experimental group

Description:

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.

Treatment:

Drug: QL-007 tablet

TDF 300 mg QD

Active Comparator group

Description:

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

Treatment:

Drug: TDF