## Protocol Section
### Identification Module
**NCT ID:** NCT06425341

**Brief Title:** A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

**Official Title:** A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

#### Organization Study ID Info
**ID:** HRS-5635-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Fujian Shengdi Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-09-19

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Fujian Shengdi Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.

### Conditions Module

**Conditions:**

- Chronic Hepatitis B

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Multi-center, random, open, parallel design

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 165

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: HRS-5635 Injection

**Label:** HRS-5635 Injection dose 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: HRS-5635 Injection

**Label:** HRS-5635 Injection dose 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: HRS-5635 Injection

**Label:** HRS-5635 Injection dose 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: HRS-5635 Injection

**Label:** HRS-5635 Injection dose 4

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HRS-5635 Injection dose 1

**Description:** HRS-5635 Injection low dose administered by subcutaneous injection

**Name:** HRS-5635 Injection

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- HRS-5635 Injection dose 2

**Description:** HRS-5635 Injection medium dose administered by subcutaneous injection

**Name:** HRS-5635 Injection

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- HRS-5635 Injection dose 3

**Description:** HRS-5635 Injection high dose administered by subcutaneous injection

**Name:** HRS-5635 Injection

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- HRS-5635 Injection dose 4

**Description:** HRS-5635 Injection lowest dose administered by subcutaneous injection

**Name:** HRS-5635 Injection

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12

**Time Frame:** Week 12

**Measure:** PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48

**Time Frame:** Week 48

#### Secondary Outcomes

**Measure:** Changes from baseline in mean log10 serum hepatitis B surface antigen levels

**Time Frame:** Pre-specified time points up to 72 weeks

**Measure:** Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen

**Time Frame:** Pre-specified time points up to 72 weeks

**Measure:** Proportion of subjects with serum hepatitis B surface antigen loss

**Time Frame:** Pre-specified time points up to 72 weeks

**Measure:** Proportion of subjects with serum hepatitis B surface antigen seroconversion

**Time Frame:** Pre-specified time points up to 72 weeks

**Measure:** Proportion of subjects with hepatitis B e-antigen loss

**Time Frame:** Pre-specified time points up to 72 weeks

**Measure:** Proportion of subjects with serum hepatitis B e-antigen seroconversion

**Time Frame:** Pre-specified time points up to 72 weeks

**Measure:** Proportion of subjects with virologic breakthrough

**Time Frame:** Pre-specified time points up to 72 weeks

**Measure:** Proportion of subjects with drug resistance

**Time Frame:** Pre-specified time points up to 72 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
5. Need to take effective contraceptive measures；
6. Volunteer to sign an informed consent.

Exclusion Criteria:

1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
2. With autoimmune disease;
3. History of solid organ transplantation or hematopoietic stem cell transplantation;
4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
5. Malignant tumors were diagnosed within 5 years prior to randomization；
6. Infection requiring intervention within 2 weeks prior to randomization;
7. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
8. Laboratory tests during the screening period were obviously abnormal;
9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
11. Participated in clinical study of other drugs (received experimental drugs);
12. Pregnant or nursing women;
13. Allergic to a drug ingredient or component;
14. Other reasons for ineligibility as judged by the investigators.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xiaopeng.wang@hengrui.com

**Name:** Xiaopeng Wang

**Phone:** 0518-82342973

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** jlhousmu@163.com

- **Name:** Jinlin Hou

- **Phone:** 020-62787432

- **Role:** CONTACT

**Country:** China

**Facility:** Nanfang Hospital

**State:** Guangdong

**Zip:** 510515

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M21609

- Name: Hepatitis B, Chronic

- Relevance: HIGH

- As Found: Chronic Hepatitis B

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: HIGH

- As Found: Chronic Hepatitis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20487

- Name: Hepadnaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006509

- Term: Hepatitis B

- ID: D000019694

- Term: Hepatitis B, Chronic

- ID: D000006505

- Term: Hepatitis

- ID: D000006521

- Term: Hepatitis, Chronic

### Misc Info Module

- Version Holder: 2024-05-31
