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

Primary Purpose

Chronic Hepatitis b

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
QL-007 tablet
TDF
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

200 mg QD

400 mg QD

600 mg QD

100 mg BID

200 mg BID

TDF 300 mg QD

Arm 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.

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.

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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
adverse events (AEs)
AEs occur during the study

Full Information

First Posted
June 20, 2018
Last Updated
December 7, 2018
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03770624
Brief Title
A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA
Acronym
QL-007
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
200 mg QD
Arm Type
Experimental
Arm 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.
Arm Title
400 mg QD
Arm Type
Experimental
Arm 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.
Arm Title
600 mg QD
Arm Type
Experimental
Arm 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.
Arm Title
100 mg BID
Arm Type
Experimental
Arm 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.
Arm Title
200 mg BID
Arm Type
Experimental
Arm 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.
Arm Title
TDF 300 mg QD
Arm Type
Active Comparator
Arm Description
TDF will be administered orally daily (300 mg QD) over the 28 days not request fast .
Intervention Type
Drug
Intervention Name(s)
QL-007 tablet
Intervention Description
QL-007 will be administered orally daily over the 28 days under fasted state.
Intervention Type
Drug
Intervention Name(s)
TDF
Intervention Description
TDF will be administered orally daily over the 28 days e.
Primary Outcome Measure Information:
Title
Change in serum HBV DNA from baseline at Day3, 8, 15, 22 and 28
Description
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 Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of QL-007 following multiple doses
Description
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
Title
The time to Cmax (tmax) of QL-007 following multiple doses
Description
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
Title
AUC0-t (area under the plasma concentration versus time curve) of QL-007 following multiple doses
Description
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
Title
AUC0-∞ of QL-007 following multiple doses following multiple doses
Description
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
Title
t1/2 (terminal elimination half-life) of QL-007 following multiple doses
Description
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
Title
Vz/F(apparent volume of distribution for the terminal disposition phase) of QL-007 following multiple doses
Description
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
Title
Change in serum HBsAg from baseline at Day 1, Day 3, Day 8, Day 15, Day 22 and Day 28
Description
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
Title
adverse events (AEs)
Description
AEs occur during the study
Time Frame
From randomization up to Day 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking University First Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang, Dr
Phone
13911405123
Email
John131212@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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