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

NCT05808374 | Unknown Phase 1

• 1 other identifier: HRS-5635-101
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events In Part 1

  A summary of adverse events, including Serious Adverse Events(SAEs)

  85 days

• Number of Adverse Events In Part 2

  A summary of adverse events, including Serious Adverse Events(SAEs)

  169 days

Secondary Outcomes (4)

• Peak Plasma Concentration (Cmax) of single dose

  8 days

• Peak Plasma Concentration (Cmax) of Multiple ascending dose

  64 days

• Time to the peak plasma concentration (Tmax) of single dose

  8 days

• Time to the peak plasma concentration (Tmax) of Multiple ascending dose

  64 days

Study Arms (3)

Part 1

EXPERIMENTAL

Single Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo

Drug: HRS-5635; Drug: Placebo

Part 2a

EXPERIMENTAL

Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo

Drug: HRS-5635; Drug: Placebo

Part 2b

EXPERIMENTAL

Patients not receiving consolidation treatment：HRS-5635 vs. Placebo

Drug: HRS-5635; Drug: Placebo

Interventions

HRS-5635 DRUG

50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635

Part 1

Placebo DRUG

Placebo

Part 1; Part 2a; Part 2b

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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）.

You may not qualify if:

• 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）.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of China University of Science and Technology

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guangming Feng

CONTACT

+0518-82342973; guangming.feng@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: April 30, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

CN (1)