Chronic Hepatitis CPhase 1/2HEC110114NCT04202952
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects
A Phase 1/2 study testing HEC110114 Tablet and Sofosbuvir Tablet in people with Chronic Hepatitis C, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- HEC110114 Tablet and Sofosbuvir Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2020to 27 Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
- Be able to complete the study according to the trail protocol;
- Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures;
- Male subjects and must be 18 to 65 years of age inclusive;
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females;
- No previous treatment with any direct-acting antiviral (DAA) drugs for HCV, such as Simeprevir, Sofosbuvir, Daclatasvir etc;
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- HCV RNA ≥10*5 IU/mL at screening (Roche COBAS Taqman);
- Chronic genotype 1-6 HCV Infection, multiple genotypes, subtype unidentifiable or others ;
- Serum ALT ≤5 times ULN.
Who cannot join
- Allergies constitution ( multiple drug and food allergies);
- History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine);
- Donation or loss of blood over 450 mL within 3 months prior to screening;
- History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc;
- 12-lead ECG with clinically significant;
- Pregnant or lactating women;
- Creatinine clearance < 60 mL/min;
- Subjects deemed unsuitable by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University
Jilin City, Changchun, 130021
About this study
Official title: A Phase Ib/IIa, Single Center, Randomized, Open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability， Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
Read the detailed description
A total of 24 evaluable patients will be enrolled in this study. The study randomly divided into three dose groups and HEC110114 tablets planned dose levels are 600, 800, and 1200 mg, sofosbuvir tablets planned dose levels are 400 mg .
- Conditions
- Chronic Hepatitis C
- Being tested
- HEC110114 Tablet, Sofosbuvir Tablet
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC110114 TabletDrug
administered orally once daily
Sofosbuvir TabletDrug
administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 600 mg multiple doses | Experimental | Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days Receives: Drug: HEC110114 Tablet; Drug: Sofosbuvir Tablet |
| 800 mg multiple doses | Experimental | Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days Receives: Drug: HEC110114 Tablet; Drug: Sofosbuvir Tablet |
| 1200 mg multiple doses | Experimental | Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days Receives: Drug: Sofosbuvir Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence of adverse events
Measured: From Days 1-10
Secondary outcomes (5)
Cmax
Maximum Observed Plasma Concentration
Measured: At pre-defined intervals from Days 1-7
Tmax
Time to Maximum Observed Plasma Concentration
Measured: At pre-defined intervals from Days 1-7
T1/2 T1/2 T1/2 T1/2
Apparent Half-Life
Measured: At pre-defined intervals from Days 1-7
AUClast
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
Measured: At pre-defined intervals from Days 1-7
HCV RNA
HCV RNA declined from baseline
Measured: At pre-defined intervals from Days 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start6 Jul 2020
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Doctor, Principal investigator, The First Hospital of Jilin UniversityYanhua Ding, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202952
- Sponsor's protocol ID
- HEC110114-P-02
- Acronym
- HEC110114
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa, Single Center, Randomized, Open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability， Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
- ClinicalTrials.gov ID
- NCT04202952
- Acronym / sponsor ID
- HEC110114 / HEC110114-P-02
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
Detailed description
A total of 24 evaluable patients will be enrolled in this study. The study randomly divided into three dose groups and HEC110114 tablets planned dose levels are 600, 800, and 1200 mg, sofosbuvir tablets planned dose levels are 400 mg .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 600 mg multiple doses | Experimental | Drug: HEC110114 Tablet, Drug: Sofosbuvir TabletSubjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days |
| 800 mg multiple doses | Experimental | Drug: HEC110114 Tablet, Drug: Sofosbuvir TabletSubjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days |
| 1200 mg multiple doses | Experimental | Drug: Sofosbuvir TabletSubjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
- Be able to complete the study according to the trail protocol;
- Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures;
- Male subjects and must be 18 to 65 years of age inclusive;
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females;
Key exclusion criteria (8 listed)
- Allergies constitution ( multiple drug and food allergies);
- History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine);
- Donation or loss of blood over 450 mL within 3 months prior to screening;
- History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc;
- 12-lead ECG with clinically significant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC110114 Tabletadministered orally once daily | Drug | 600 mg multiple doses, 800 mg multiple doses |
| Sofosbuvir Tabletadministered orally once daily | Drug | 1200 mg multiple doses, 600 mg multiple doses, 800 mg multiple doses |
Primary outcome
Adverse Events
Time frame: From Days 1-10
Incidence of adverse events
5 secondary outcomes
Cmax
Time frame: At pre-defined intervals from Days 1-7
Tmax
Time frame: At pre-defined intervals from Days 1-7
T1/2 T1/2 T1/2 T1/2
Time frame: At pre-defined intervals from Days 1-7
AUClast
Time frame: At pre-defined intervals from Days 1-7
HCV RNA
Time frame: At pre-defined intervals from Days 1-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junqi Niu, Doctor principal investigator
The First Hospital of Jilin University
Yanhua Ding, Doctor principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HEC110114 Tablet and Sofosbuvir Tablet in people with Chronic Hepatitis C, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From Days 1-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.