NCT03770624 - A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

60

Conditions

Chronic Hepatitis b

Interventions

QL-007 tabletDRUG

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

TDFDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Change in serum HBV DNA from baseline at Day3, 8, 15, 22 and 28

Blood samples will be collected on Day -1 , 1, 3, 8, 15, 22, 28 and the follow-up 7 ±1 days

Time frame: Time Frame: Day 1, Day 3, Day 8, Day 15, Day 22 and Day 28

Secondary Outcomes

Peak Plasma Concentration (Cmax) of QL-007 following multiple doses

Concentrations of QL-007 in plasma will be collected on Day 1, Day 3, Day 8, Day 15, Day 22 and Day 28.

Time frame: Days 1, 3, 8, 15, 22, and 28. On Days 1, 3, 8, 15, 22, and 28, samples will be collected predose; on Days 1 and 28, samples will also be collected at 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h postdose

The time to Cmax (tmax) of QL-007 following multiple doses

Concentrations of QL-007 in plasma will be collected on Day 1, Day 3, Day 8, Day 15, Day 22 and Day 28.

Time frame: Days 1, 3, 8, 15, 22, and 28. On Days 1, 3, 8, 15, 22, and 28, samples will be collected predose; on Days 1 and 28, samples will also be collected at 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h postdose

AUC0-t (area under the plasma concentration versus time curve) of QL-007 following multiple doses

Concentrations of QL-007 in plasma will be collected on Day 1, Day 3, Day 8, Day 15, Day 22 and Day 28.

Time frame: Days 1, 3, 8, 15, 22, and 28. On Days 1, 3, 8, 15, 22, and 28, samples will be collected predose; on Days 1 and 28, samples will also be collected at 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h postdose

AUC0-∞ of QL-007 following multiple doses following multiple doses

Concentrations of QL-007 in plasma will be collected on Day 1, Day 3, Day 8, Day 15, Day 22 and Day 28.

Time frame: Days 1, 3, 8, 15, 22, and 28. On Days 1, 3, 8, 15, 22, and 28, samples will be collected predose; on Days 1 and 28, samples will also be collected at 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h postdose