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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808374
• Other study ID #: HRS-5635-101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 30, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: Guangming Feng
• Phone: +0518-82342973
• Email: guangming.feng[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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).

2. Age 18-55 (including boundary value) (In healthy people); Age 18-65 (including boundary value) (In chronic hepatitis B).

3. Male weight = 50 kg, female weight = 45 kg, body mass index (BMI) 18~28 kg/m2 (including boundary value) (In healthy people).

4. Normal or abnormal vital signs, physical examination, laboratory examination, chest radiograph, etc. have no clinical significance(In healthy people).

5. 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).

Exclusion Criteria:

1. 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).

2. Previous history of malignant tumor(In healthy people).

3. 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).

4. 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).

5. 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)).

6. 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).

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• HRS-5635
50mg HRS-5635;100mg HRS-5635;200mg HRS-5635;400mg HRS-5635;600mg HRS-5635;800mg HRS-5635
• HRS-5635
100mg HRS-5635,Q4W;200mg HRS-5635 ,Q4W;400mg HRS-5635,Q4W;200mg HRS-5635, Q2W
• HRS-5635
200mg HRS-5635,Q4W
• Placebo
Placebo

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China University of Science and Technology	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events In Part 1	A summary of adverse events, including Serious Adverse Events(SAEs)	85 days
Primary	Number of Adverse Events In Part 2	A summary of adverse events, including Serious Adverse Events(SAEs)	169 days
Secondary	Peak Plasma Concentration (Cmax) of single dose		8 days
Secondary	Peak Plasma Concentration (Cmax) of Multiple ascending dose		64 days
Secondary	Time to the peak plasma concentration (Tmax) of single dose		8 days
Secondary	Time to the peak plasma concentration (Tmax) of Multiple ascending dose		64 days