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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Placebo; Drug: HRS-5635; Drug: HRS-5635; Drug: HRS-5635

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guangming Feng; Phone Number: +0518-82342973; Email: guangming.feng@hengrui.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • The First Affiliated Hospital of China University of Science and Technology
      • Contact: Aizong Shen; Phone Number: +86-18963789019; Email: 1649441800@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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）.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Single Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo	Drug: Placebo; Placebo; Drug: HRS-5635; 100mg HRS-5635，Q4W；200mg HRS-5635 ，Q4W；400mg HRS-5635，Q4W；200mg HRS-5635, Q2W; Drug: HRS-5635; 200mg HRS-5635，Q4W; Drug: HRS-5635; 50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635
Experimental: Part 2a; Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo	Drug: Placebo; Placebo; Drug: HRS-5635; 100mg HRS-5635，Q4W；200mg HRS-5635 ，Q4W；400mg HRS-5635，Q4W；200mg HRS-5635, Q2W; Drug: HRS-5635; 200mg HRS-5635，Q4W; Drug: HRS-5635; 50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635
Experimental: Part 2b; Patients not receiving consolidation treatment：HRS-5635 vs. Placebo	Drug: Placebo; Placebo; Drug: HRS-5635; 100mg HRS-5635，Q4W；200mg HRS-5635 ，Q4W；400mg HRS-5635，Q4W；200mg HRS-5635, Q2W; Drug: HRS-5635; 200mg HRS-5635，Q4W; Drug: HRS-5635; 50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: HRS-5635-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No