NCT03244085

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

An Open-Label Phase 1b Study to Evaluate the Dose-Related Safety, Efficacy, and Pharmacokinetic Profile of Different Doses of QL-007 in Chronic Hepatitis B Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a nonrandomized, open-label, no-control, dose-escalation Phase 1b trial in 18 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 mg/day (100 mg two times a day (BID)), 400 mg/day (200 mg BID), then 600 mg once daily (QD), with 6 patients for each cohort.

Detailed description

Administration of the next dose level will occur only if the preceding dose was determined to be safe and well tolerated. The decision to proceed to the next higher dose level will be made by a Safety Review Committee (SRC) based upon review of efficacy and safety data including AEs, safety laboratory results, vital signs and ECGs. PK data for up to 12 hours post-dose will also be reviewed. The review will be conducted after the last subject in a cohort completes the Day 28 visit. The planned dose levels can be modified based on the data reviewed.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	QL-007 tablet	Patients will be enrolled in 1 of 3 cohorts (6 patients per cohort): QL 007 200 mg/day (100 mg BID), or QL 007 400 mg/day (200 mg/BID), or QL 007 600 mg QD. QL 007 will be administered orally daily over the 28 days under fasted state. Patients fast for 2h before administration and 1h after administration.

Timeline

• Start date: 2017-08-20
• Primary completion: 2018-10-30
• Completion: 2018-12-30
• First posted: 2017-08-09
• Last updated: 2018-07-16

Locations

1 site across 1 country: New Zealand