A Phase 1 interventional study of QL-007 tablet and TDF in Chronic Hepatitis b, sponsored by Qilu Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-10.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
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.
Drug: QL-007 tablet
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.
Drug: QL-007 tablet
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.
Drug: QL-007 tablet
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.
Drug: QL-007 tablet
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.
Drug: QL-007 tablet
TDF will be administered orally daily (300 mg QD) over the 28 days not request fast .
Drug: TDF
QL-007 will be administered orally daily over the 28 days under fasted state.
TDF will be administered orally daily over the 28 days e.
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
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
t1/2 (terminal elimination half-life) 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
Vz/F(apparent volume of distribution for the terminal disposition phase) 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
Change in serum HBsAg from baseline at Day 1, Day 3, Day 8, Day 15, Day 22 and Day 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
adverse events (AEs)
AEs occur during the study
Time frame: From randomization up to Day 35
Plan to share: No
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Qilu Pharmaceutical Co., Ltd.