Trials / Unknown
UnknownNCT03770624
A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA
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
- 60 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL-007 tablet | QL-007 will be administered orally daily over the 28 days under fasted state. |
| DRUG | TDF | TDF will be administered orally daily over the 28 days e. |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2019-03-30
- Completion
- 2019-04-30
- First posted
- 2018-12-10
- Last updated
- 2018-12-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03770624. Inclusion in this directory is not an endorsement.