Evaluating a new injection for chronic hepatitis B and healthy adults

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

This study is testing a new injection for chronic hepatitis B to see how safe it is and how well it works in both healthy adults and patients with the condition.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT05808374 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety, tolerability, and pharmacokinetics of HRS-5635 in both healthy adults and patients with chronic hepatitis B. It involves administering a single dose to healthy subjects and multiple doses to hepatitis B patients to determine the appropriate dosage and evaluate the antiviral effects. The study will monitor participants for any adverse effects and measure how the drug is processed in the body. The goal is to gather comprehensive data on the drug's safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-55 and patients with chronic hepatitis B aged 18-65.

Not a fit: Patients with serious clinical diseases affecting various body systems may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with chronic hepatitis B.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating antiviral treatments for chronic hepatitis B.

Eligibility criteria

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）.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of China University of Science and Technology — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Guangming Feng

Conditions: Chronic Hepatitis B