Chronic Hepatitis BPhase 1NCT05808374
Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B
A Phase 1 study testing HRS-5635 in people with Chronic Hepatitis B, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HRS-5635
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2023to 31 May 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understand the specific process of the test, voluntarily participate in the test, and sign the informed consent form in writing（In healthy people and chronic hepatitis B）.
- Age 18-55 (including boundary value) （In healthy people）; Age 18-65 (including boundary value) （In chronic hepatitis B）.
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) 18~28 kg/m2 (including boundary value) （In healthy people）.
- Normal or abnormal vital signs, physical examination, laboratory examination, chest radiograph, etc. have no clinical significance（In healthy people）.
- Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months after screening and the last study drug administration（In healthy people）.
Who cannot join
- Those suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results（In healthy people）.
- Previous history of malignant tumor（In healthy people）.
- Those who have digestive system disease or serious digestive system disease at present or in the near future (within one month), and the researcher believes that it may affect drug absorption or have safety risk（In healthy people）.
- Those who have serious infection, serious injury or major surgery within 3 months before administration; Those who plan to undergo surgery during the trial and within two weeks after the end of the trial（In healthy people）.
- Serious cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled conditions, including but not limited to myocardial infarction, unstable angina pectoris, heart failure, and moderate stroke（（In chronic hepatitis B））.
- Clinically significant liver diseases caused by other causes (such as alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced liver injury, alcoholic hepatitis, etc.); （In chronic hepatitis B）.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China University of Science and Technology
Hefei, Anhui, 230001
Aizong Shen, +86-18963789019, 1649441800@qq.com
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
- Conditions
- Chronic Hepatitis B
- Being tested
- HRS-5635, Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5635Drug
50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635
HRS-5635Drug
100mg HRS-5635，Q4W；200mg HRS-5635 ，Q4W；400mg HRS-5635，Q4W；200mg HRS-5635, Q2W
HRS-5635Drug
200mg HRS-5635，Q4W
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Single Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo Receives: Drug: HRS-5635; Drug: Placebo |
| Part 2a | Experimental | Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo Receives: Drug: HRS-5635; Drug: Placebo |
| Part 2b | Experimental | Patients not receiving consolidation treatment：HRS-5635 vs. Placebo Receives: Drug: HRS-5635; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events In Part 1
A summary of adverse events, including Serious Adverse Events(SAEs)
Measured: 85 days
Number of Adverse Events In Part 2
A summary of adverse events, including Serious Adverse Events(SAEs)
Measured: 169 days
Secondary outcomes (4)
Peak Plasma Concentration (Cmax) of single dose
Measured: 8 days
Peak Plasma Concentration (Cmax) of Multiple ascending dose
Measured: 64 days
Time to the peak plasma concentration (Tmax) of single dose
Measured: 8 days
Time to the peak plasma concentration (Tmax) of Multiple ascending dose
Measured: 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start30 Apr 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808374
- Sponsor's protocol ID
- HRS-5635-101
- Status last verified
- Jun 2023
- First submitted
- 29 Mar 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT05808374
- Acronym / sponsor ID
- HRS-5635-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 11 Apr 2023 (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 study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: HRS-5635, Drug: PlaceboSingle Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo |
| Part 2a | Experimental | Drug: HRS-5635, Drug: PlaceboMultiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo |
| Part 2b | Experimental | Drug: HRS-5635, Drug: PlaceboPatients not receiving consolidation treatment：HRS-5635 vs. Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Understand the specific process of the test, voluntarily participate in the test, and sign the informed consent form in writing（In healthy people and chronic hepatitis B）.
- Age 18-55 (including boundary value) （In healthy people）; Age 18-65 (including boundary value) （In chronic hepatitis B）.
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) 18~28 kg/m2 (including boundary value) （In healthy people）.
- Normal or abnormal vital signs, physical examination, laboratory examination, chest radiograph, etc. have no clinical significance（In healthy people）.
- Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months after screening and the last study drug administration（In healthy people）.
Key exclusion criteria (6 listed)
- Those suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results（In healthy people）.
- Previous history of malignant tumor（In healthy people）.
- Those who have digestive system disease or serious digestive system disease at present or in the near future (within one month), and the researcher believes that it may affect drug absorption or have safety risk（In healthy people）.
- Those who have serious infection, serious injury or major surgery within 3 months before administration; Those who plan to undergo surgery during the trial and within two weeks after the end of the trial（In healthy people）.
- Serious cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled conditions, including but not limited to myocardial infarction, unstable angina pectoris, heart failure, and moderate stroke（（In chronic hepatitis B））.
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 |
|---|---|---|
| HRS-563550mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635 | Drug | Part 1 |
| HRS-5635100mg HRS-5635，Q4W；200mg HRS-5635 ，Q4W；400mg HRS-5635，Q4W；200mg HRS-5635, Q2W | Drug | Part 2a |
| HRS-5635200mg HRS-5635，Q4W | Drug | Part 2b |
| PlaceboPlacebo | Drug | Part 1, Part 2a, Part 2b |
Primary outcome
Number of Adverse Events In Part 1
Time frame: 85 days
A summary of adverse events, including Serious Adverse Events(SAEs)
Number of Adverse Events In Part 2
Time frame: 169 days
A summary of adverse events, including Serious Adverse Events(SAEs)
4 secondary outcomes
Peak Plasma Concentration (Cmax) of single dose
Time frame: 8 days
Peak Plasma Concentration (Cmax) of Multiple ascending dose
Time frame: 64 days
Time to the peak plasma concentration (Tmax) of single dose
Time frame: 8 days
Time to the peak plasma concentration (Tmax) of Multiple ascending dose
Time frame: 64 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 HRS-5635 in people with Chronic Hepatitis B, run by Fujian Shengdi 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangming Feng (+0518-82342973, guangming.feng@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events In Part 1 (time frame: 85 days). 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 18 Jun 2023.