HCV InfectionPhase 1NCT03588923
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With HCV Infection
A Phase 1 study testing SH229 in people with HCV Infection, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of single and multiple ascending doses of SH229 in patients with chronic hepatitis C Virus infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HCV Infection
- What is being tested?
- SH229
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2018to 10 Aug 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose;
- 18-65 years of age;
- 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 Boceprevir, Telaprevir, Simeprevir, Sofosbuvir, Daclatasvir, Asunaprevir;
- No antiviral treatment such as immune modulators, thymosin or other immune stimulating factors, interferon, or Chinese herbs in the past 6 months;
- HCV RNA ≥10*5 IU/mL at screening (Roche COBAS Taqman);
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- Chronic genotype 1-6 HCV Infection;
- Serum ALT ≤10 times ULN;
- FibroScan score ≤17.5kPa within 6 months before screening or at screening, or absence of cirrhosis within 12 months before screening;
- Subjects are capable of understanding and complying with the protocol and have signed the informed consent form.
Who cannot join
- Smoke more than 5 cigarettes per day within three months prior to screening;
- Subjects allergic to the study drug (including its excipients) or subjects who are prone to allergies;
- History of drug and/or alcohol abuse (alcohol consumption exceeding 14 units per week: 1 unit = 285 mL of beer, or 25 mL of hard liquor, or 100 mL of wine);
- Blood donation or massive blood loss (> 450 mL) within three 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.;
- Subjects with dysphagia or with any gastrointestinal disorders (or postoperative conditions) that may affect the study drug absorption;
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- Subjects with any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
- Use of any drugs that alter liver enzyme activity within 28 days prior to screening;
- Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening;
- Use of special diet (including dragon fruit, mango, grapefruit, etc.), strenuous activities or other factors that may affect the disposition of the study drug within 2 weeks prior to screening;
- Concomitant use of strong inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone;
- Subjects with major changes in diet or exercise habits recently;
- Participation in other clinical trials within three months prior to enrollment;
- Electrocardiogram abnormalities with clinical significance;
- Laboratory tests with clinical significance or other clinical findings that indicate clinically significant diseases not associated with HCV infection (including but not limited to gastrointestinal, renal, hepatic, neurologic, hematological, endocrine, pulmonary, psychiatric, cardiovascular diseases);
- Pregnant or lactating women;
- Creatinine clearance ≤ 60 mL/min;
- Evidence of co-infection with HBV, HIV, or syphilis;
- Child-Pugh Grade B or C;
- Clinically significant hepatic decompensation including but not limited to, hepatic encephalopathy, hepatocellular carcinoma, variceal bleeding, ascites, etc.;
- Use of chocolate, food or beverages containing caffeine or xanthine within 24 hours prior to dosing;
- Use of products containing alcohol within 24 hours prior to dosing;
- Subjects with urine drug screening test positive, or with history of drug abuse in the past 5 years;
Trial locations and contacts
1 site in 1 country.
China1 site
Phase I Clinical Trial Unit, The First Hospital of Jilin University
Changchun, Jilin, 130000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Study to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With Hepatitis C Virus (HCV) Infection
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of single and multiple ascending doses of SH229 in patients with chronic hepatitis C Virus infection.
Read the detailed description
A total of 30 evaluable patients will be enrolled in this study. The planned dose levels are 400, 600, and 800 mg.
- Conditions
- HCV Infection
- Being tested
- SH229, Placebos
- Keywords
- HCV, NS5B, SH229
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH229Drug
tablet, oral, 400 mg once daily for 3 days
PlacebosDrug
tablet, oral, once daily for 3 days
SH229Drug
tablet, oral, 600 mg once daily for 3 days
PlacebosDrug
tablet, oral, once daily for 3 days
SH229Drug
tablet, oral, 800 mg once daily for 3 days
PlacebosDrug
tablet, oral, once daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | SH229 (400 mg) or matching placebo, once daily Receives: Drug: SH229; Drug: Placebos |
| Cohort 2 | Active comparator | SH229 (600 mg) or matching placebo, once daily Receives: Drug: SH229; Drug: Placebos |
| Cohort 3 | Active comparator | SH229 (800 mg) or matching placebo, once daily Receives: Drug: SH229; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: up to Day 10
Antiviral effects of SH229, as measured by HCV RNA levels
Measured: up to Day 10
Secondary outcomes (4)
Time to peak plasma concentration(Tmax)
Measured: up to Day 10
Peak plasma concentration(Cmax)
Measured: up to Day 10
Half-life time(t1/2)
Measured: up to Day 10
Area under the plasma concentration versus time curve(AUC)
Measured: up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start7 Jul 2018
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, MD, Principal investigator, Phase I Clinical Trial Unit, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588923
- Sponsor's protocol ID
- SHC005-I-03
- Status last verified
- Aug 2018
- First submitted
- 2 Jul 2018
- Last updated
- 28 Aug 2018
- 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 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Study to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With Hepatitis C Virus (HCV) Infection
- ClinicalTrials.gov ID
- NCT03588923
- Acronym / sponsor ID
- SHC005-I-03
- Conditions
- HCV Infection
- Keywords
- HCV, NS5B, SH229
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2018 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 17 Jul 2018 (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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of single and multiple ascending doses of SH229 in patients with chronic hepatitis C Virus infection.
Detailed description
A total of 30 evaluable patients will be enrolled in this study. The planned dose levels are 400, 600, and 800 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: SH229, Drug: PlacebosSH229 (400 mg) or matching placebo, once daily |
| Cohort 2 | Active comparator | Drug: SH229, Drug: PlacebosSH229 (600 mg) or matching placebo, once daily |
| Cohort 3 | Active comparator | Drug: SH229, Drug: PlacebosSH229 (800 mg) or matching placebo, once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose;
- 18-65 years of age;
- 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 Boceprevir, Telaprevir, Simeprevir, Sofosbuvir, Daclatasvir, Asunaprevir;
- No antiviral treatment such as immune modulators, thymosin or other immune stimulating factors, interferon, or Chinese herbs in the past 6 months;
Key exclusion criteria (23 listed)
- Smoke more than 5 cigarettes per day within three months prior to screening;
- Subjects allergic to the study drug (including its excipients) or subjects who are prone to allergies;
- History of drug and/or alcohol abuse (alcohol consumption exceeding 14 units per week: 1 unit = 285 mL of beer, or 25 mL of hard liquor, or 100 mL of wine);
- Blood donation or massive blood loss (> 450 mL) within three 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.;
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 |
|---|---|---|
| SH229tablet, oral, 400 mg once daily for 3 days | Drug | Cohort 1 |
| Placebostablet, oral, once daily for 3 days | Drug | Cohort 1 |
| SH229tablet, oral, 600 mg once daily for 3 days | Drug | Cohort 2 |
| Placebostablet, oral, once daily for 3 days | Drug | Cohort 2 |
| SH229tablet, oral, 800 mg once daily for 3 days | Drug | Cohort 3 |
| Placebostablet, oral, once daily for 3 days | Drug | Cohort 3 |
Primary outcome
Incidence of adverse events
Time frame: up to Day 10
Antiviral effects of SH229, as measured by HCV RNA levels
Time frame: up to Day 10
4 secondary outcomes
Time to peak plasma concentration(Tmax)
Time frame: up to Day 10
Peak plasma concentration(Cmax)
Time frame: up to Day 10
Half-life time(t1/2)
Time frame: up to Day 10
Area under the plasma concentration versus time curve(AUC)
Time frame: up to Day 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 28 Aug 2018.
- 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.
Yanhua Ding, MD principal investigator
Phase I Clinical Trial Unit, 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 SH229 in people with HCV Infection, run by Nanjing Sanhome Pharmaceutical, 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 10 inclusion and 23 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 28 Aug 2018. 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?
Incidence of adverse events (time frame: up to Day 10). The study lists 2 primary outcomes in all. 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 28 Aug 2018.