## Protocol Section
### Identification Module
**NCT ID:** NCT06435676

**Brief Title:** A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects

**Official Title:** A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects

#### Organization Study ID Info
**ID:** HRS9531-T-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Fujian Shengdi Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-26
### 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:** The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.

### Conditions Module

**Conditions:**

- Overweight or Obesity; Type 2 Diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** randomized, double-blind, placebo-controlled

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 92

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Administered po once

**Intervention Names:**

- Drug: HRS9531

**Label:** SAD Stage: HRS9531

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Administered po once

**Intervention Names:**

- Drug: Placebo

**Label:** SAD Stage: placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** Administered po for multiple dose

**Intervention Names:**

- Drug: HRS9531

**Label:** MAD Stage: HRS9531

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Administered po for multiple dose

**Intervention Names:**

- Drug: Placebo

**Label:** MAD Stage: placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SAD Stage: HRS9531

**Description:** Single dose escalation of HRS9531 tablets in healthy subjects

**Name:** HRS9531

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- SAD Stage: placebo

**Description:** Single dose of placebo in healthy adults

**Name:** Placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- MAD Stage: HRS9531

**Description:** Multiple dose escalation of HRS9531 tablets in healthy subjects

**Name:** HRS9531

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- MAD Stage: placebo

**Description:** Multiple dose of placebo in healthy adults

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** SAD Stage: Number of Adverse Events

**Time Frame:** 36 days

**Measure:** MAD Stage: Number of Adverse Events

**Time Frame:** 63 days

#### Secondary Outcomes

**Description:** Tmax of a single dose of HRS9531 tablets

**Measure:** Plasma Concentration-Time to Peak (Tmax) of HRS9531

**Time Frame:** 36 days

**Description:** AUC of a single dose of HRS9531 tablets

**Measure:** Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531

**Time Frame:** 36 days

**Description:** anti-HRS9531 antibody

**Measure:** Immunogenicity qualitative

**Time Frame:** 36 days

**Description:** Tmax of multiple dose of HRS9531 tablets

**Measure:** Plasma Concentration-Time to Peak (Tmax) of HRS9531

**Time Frame:** 63 days

**Description:** AUC of multiple dose of HRS9531 tablets

**Measure:** Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531

**Time Frame:** 63 days

**Description:** fasting plasma glucose

**Measure:** Glucose

**Time Frame:** 35 days

**Description:** anti-HRS9531 antibody

**Measure:** Immunogenicity qualitative

**Time Frame:** 63 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Ability to understand the trial procedures, be able and willing to provide a written informed consent.
2. 18-55 years of age at the time of signing informed consent.
3. SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
4. Subjects with good general health, no clinically significant abnormalities.

Exclusion Criteria:

1. Known or suspected hypersensitivity to trial product(s) or related products.
2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
3. Abnormal and clinically significant blood pressure at screening.
4. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
5. Participation in other clinical trials.
6. Presence of any clinically significant results in examination at screening visit.
7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
8. Presence of - clinically significant ECG results.
9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
10. Addiction to tobacco and alcohol.
11. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hongcheng.hu@hengrui.com

**Name:** Hongcheng Hu

**Phone:** 0518-82342973

**Role:** CONTACT

**Contact 2:**

**Email:** jianting.han.jh27@hengrui.com

**Name:** Jianting Han

**Phone:** 15620796974

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hefei

**Contacts:**

***Contact 1:***

- **Email:** hwgcp@ayefy.com

- **Name:** Wei Hu, Doctor

- **Phone:** 86+13856086475

- **Role:** CONTACT

***Contact 2:***

- **Email:** 2460679232@qq.com

- **Name:** Yijun Du, Doctor

- **Phone:** 86+13866700016

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Hospital Of Anhui medical University

**State:** Anhui

**Zip:** 230601

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

### Misc Info Module

- Version Holder: 2024-05-31
