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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

Primary Purpose

Chronic Hepatitis B

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HRS-5635
HRS-5635
HRS-5635
Placebo
Sponsored by
Fujian Shengdi Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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).

Sites / Locations

  • The First Affiliated Hospital of China University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1

Part 2a

Part 2b

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of Adverse Events In Part 1
A summary of adverse events, including Serious Adverse Events(SAEs)
Number of Adverse Events In Part 2
A summary of adverse events, including Serious Adverse Events(SAEs)

Secondary Outcome Measures

Peak Plasma Concentration (Cmax) of single dose
Peak Plasma Concentration (Cmax) of Multiple ascending dose
Time to the peak plasma concentration (Tmax) of single dose
Time to the peak plasma concentration (Tmax) of Multiple ascending dose

Full Information

First Posted
March 29, 2023
Last Updated
June 15, 2023
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05808374
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1
Arm Type
Experimental
Arm Description
Single Dose Incremental (SAD) Trial - Healthy Persons:HRS-5635 vs. Placebo
Arm Title
Part 2a
Arm Type
Experimental
Arm Description
Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy:HRS-5635 vs. Placebo
Arm Title
Part 2b
Arm Type
Experimental
Arm Description
Patients not receiving consolidation treatment:HRS-5635 vs. Placebo
Intervention Type
Drug
Intervention Name(s)
HRS-5635
Intervention Description
50mg HRS-5635;100mg HRS-5635;200mg HRS-5635;400mg HRS-5635;600mg HRS-5635;800mg HRS-5635
Intervention Type
Drug
Intervention Name(s)
HRS-5635
Intervention Description
100mg HRS-5635,Q4W;200mg HRS-5635 ,Q4W;400mg HRS-5635,Q4W;200mg HRS-5635, Q2W
Intervention Type
Drug
Intervention Name(s)
HRS-5635
Intervention Description
200mg HRS-5635,Q4W
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Adverse Events In Part 1
Description
A summary of adverse events, including Serious Adverse Events(SAEs)
Time Frame
85 days
Title
Number of Adverse Events In Part 2
Description
A summary of adverse events, including Serious Adverse Events(SAEs)
Time Frame
169 days
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of single dose
Time Frame
8 days
Title
Peak Plasma Concentration (Cmax) of Multiple ascending dose
Time Frame
64 days
Title
Time to the peak plasma concentration (Tmax) of single dose
Time Frame
8 days
Title
Time to the peak plasma concentration (Tmax) of Multiple ascending dose
Time Frame
64 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangming Feng
Phone
+0518-82342973
Email
guangming.feng@hengrui.com
Facility Information:
Facility Name
The First Affiliated Hospital of China University of Science and Technology
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aizong Shen
Phone
+86-18963789019
Email
1649441800@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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