Chronic Hepatitis CPhase 1HEC110114NCT03903081
The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects
A Phase 1 study testing HEC110114 tablet in people with Chronic Hepatitis C, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- HEC110114 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2019to 29 Oct 2019
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- 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 45 years of age inclusive
- Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive
- Physical examination and vital signs without clinically significant abnormalities.
Who cannot join
- Use of >5 cigarettes per day during the past 3 months
- 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
- 12-lead ECG with clinically significant
- Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
- Subjects deemed unsuitable by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
- Conditions
- Chronic Hepatitis C
- Being tested
- HEC110114 tablet, Placebo Oral 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
Placebo Oral TabletDrug
Placebo will be administered orally at a dose and frequency matched to HEC110114
| Study group | Role | What they receive |
|---|---|---|
| 100 mg single dose | Experimental | It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2) Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 300 mg single dose | Experimental | Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2) Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 600 mg single dose | Experimental | Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2) Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 800 mg single dose | Experimental | Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 1000 mg single dose | Experimental | Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2) Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 1200 mg single dose | Experimental | Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2) Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 1600 mg single dose | Experimental | Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2) Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 600 mg multiple doses | Experimental | Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 800 mg multiple doses | Experimental | Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
| 1000 mg multiple doses | Experimental | Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days Receives: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Percentage of Participants with Adverse Events
Measured: From Days 1-12
Secondary outcomes (7)
Cmax
Maximum Observed Plasma Concentration
Measured: At pre-defined intervals from Days 1-12
Tmax
Time to Maximum Observed Plasma Concentration
Measured: At pre-defined intervals from Days 1-12
AUClast
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
Measured: At pre-defined intervals from Days 1-12
AUC0-∞
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity
Measured: At pre-defined intervals from Days 1-12
T1/2
Apparent Half-Life
Measured: At pre-defined intervals from Days 1-12
CL/F
Clearance (CL/F) of HEC110114
Measured: At pre-defined intervals from Days 1-12
Cmin
Trough Plasma Concentration of HEC110114
Measured: At pre-defined intervals from Days 1-11 for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start6 Mar 2019
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903081
- Sponsor's protocol ID
- HEC110114-P-01
- Acronym
- HEC110114
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03903081
- Acronym / sponsor ID
- HEC110114 / HEC110114-P-01
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 4 Apr 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 I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 100 mg single dose | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletIt includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 300 mg single dose | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 600 mg single dose | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 800 mg single dose | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study |
| 1000 mg single dose | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 1200 mg single dose | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 1600 mg single dose | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 600 mg multiple doses | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days |
| 800 mg multiple doses | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days |
| 1000 mg multiple doses | Experimental | Drug: HEC110114 tablet, Drug: Placebo Oral TabletHealthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 45 years of age inclusive
- Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive
Key exclusion criteria (7 listed)
- Use of >5 cigarettes per day during the past 3 months
- 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
- 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 | 100 mg single dose, 1000 mg multiple doses, 1000 mg single dose, 1200 mg single dose, 1600 mg single dose, 300 mg single dose, 600 mg multiple doses, 600 mg single dose, 800 mg multiple doses, 800 mg single dose |
| Placebo Oral TabletPlacebo will be administered orally at a dose and frequency matched to HEC110114 | Drug | 100 mg single dose, 1000 mg multiple doses, 1000 mg single dose, 1200 mg single dose, 1600 mg single dose, 300 mg single dose, 600 mg multiple doses, 600 mg single dose, 800 mg multiple doses, 800 mg single dose |
Primary outcome
Adverse Events
Time frame: From Days 1-12
Percentage of Participants with Adverse Events
7 secondary outcomes
Cmax
Time frame: At pre-defined intervals from Days 1-12
Tmax
Time frame: At pre-defined intervals from Days 1-12
AUClast
Time frame: At pre-defined intervals from Days 1-12
AUC0-∞
Time frame: At pre-defined intervals from Days 1-12
T1/2
Time frame: At pre-defined intervals from Days 1-12
CL/F
Time frame: At pre-defined intervals from Days 1-12
Cmin
Time frame: At pre-defined intervals from Days 1-11 for MAD
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 18 Mar 2020.
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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.
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 study testing HEC110114 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 6 inclusion and 7 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 18 Mar 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 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.
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 1-12). 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 18 Mar 2020.