A Trial of HRS-9813 in Healthy Subjects

NCT06821464 | Recruiting Phase 1

• 1 other identifier: HRS-9813-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects.

Conditions

Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Safety outcomes: Incidence and severity of AEs.

  Day -14 to Day 22

Secondary Outcomes (11)

• Area under the drug-time curve

  Day 1 to Day 22

• Area under the steady-state drug-time curve within the dosing interval

  Day 1 to Day 22

• Peak concentration

  Day 1 to Day 22

• Time to peak

  Day 1 to Day 22

• Half-life

  Day 1 to Day 22

Study Arms (2)

Treatment group A

EXPERIMENTAL

Low dose

Drug: HRS-9813

Treatment group B

EXPERIMENTAL

High dose

Drug: HRS-9813

Interventions

HRS-9813 DRUG

Initial dose to planned dose（low dose）

Treatment group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily sign the informed consent form before the start of activities related to this trial, and be able to fully understand the procedures, methods, contents and possible adverse reactions of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial.
• Aged 18-45 years (inclusive), healthy male or female;
• Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2 (inclusive), body mass index (BMI) = weight (kg)/(height/100)2 (m2);
• Physical examination, vital signs, 12-lead electrocardiogram, chest anteroposterior and lateral radiographs, abdominal ultrasound and laboratory tests during the screening and baseline periods were normal, or slightly abnormal but clinically insignificant as determined by the researchers;
• Female subjects with fertility and male subjects whose partners are women of childbearing age have taken contraceptive measures within 2 weeks before signing the informed consent form, and are willing to abstain from sex or agree to contraception from the signing of the informed consent form until the end of the follow-up period (non-drug contraception is required during the trial, see Section 13.1.2 for details), and have no plans to have children or donate sperm/eggs.

You may not qualify if:

• The following diseases or treatment history:
• Any serious clinical diseases such as urinary system, circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic disorders in the past or currently, or any other diseases that the investigators judge may interfere with the results of the trial, such as intestinal diseases (including irritable bowel syndrome) and urinary tract infection/stones, etc.;
• History of malignant tumors (cancers that have been confirmed to have been cured or relieved for ≥5 years, except for radically resected basal cell or squamous cell skin cancer, cervical cancer in situ and resected colon polyps);
• Any conditions or diseases that affect the absorption, metabolism and/or excretion of the study drug;
• Severe infection, severe trauma or major surgery within 3 months before the screening period or baseline period; or plan to undergo surgery during the trial;
• Have used any drug in the 2 weeks before the screening or baseline period (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, dietary supplements, vitamin A and its derivatives, etc., excluding other conventional vitamins and occasional use of acetaminophen), or still within 5 half-lives of the drug during the screening or baseline period (whichever is longer); plan to use non-test drugs during the trial;
• Participated in clinical trials of any other drugs or medical devices within 3 months before the screening or baseline period or planned to participate in the study period, or still within 5 half-lives of the drug during the screening or baseline period (whichever is longer);
• Any of the following examinations during screening meet the following criteria:
• During the screening or baseline period, sitting systolic blood pressure \<90 mmHg or sitting diastolic blood pressure \<60 mmHg;
• During the screening or baseline period, orthostatic hypotension occurs (retest within 15 minutes to confirm);
• During the screening or baseline period, abnormal and clinically significant 12-lead electrocardiogram results, male QTcB\>450ms, female QTcB\>460ms;
• During the screening or baseline period, serum creatinine exceeding the upper limit of normal (ULN);
• During the screening or baseline period, eGFR \< 70 mL/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2) = 175×(serum creatinine/88.4)-1.234×age-0.179×(0.79 female), where serum creatinine units are μmol/L);
• During the screening or baseline period, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 1.2 times ULN, or total bilirubin exceeding 1.5 times ULN;
• During the screening period, any one of the following items is positive: hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus antibody, syphilis spirochete antibody or hepatitis C virus antibody;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ruifang Guan

CONTACT

+86 19916921632; ruifang.guan.rg1@hengrui.com

Sheng Feng

CONTACT

+86 021-61053363; sheng.feng@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 12, 2025
• Study Start: February 17, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)