What Is HRS-9813?
HRS-9813 is a medication currently under investigation in clinical trials. While the specific mechanism by which HRS-9813 works is not detailed in the available trial descriptions, it is being studied as a capsule formulation. This drug is being explored for its potential therapeutic effects in treating serious lung conditions, including Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF), and Progressive Pulmonary Fibrosis (PPF). These conditions are characterized by the scarring and stiffening of lung tissue, which can severely impair breathing and lung function.
In addition to studies in patients with these lung diseases, HRS-9813 is also being administered to healthy volunteers. These studies aim to thoroughly evaluate the drug's safety profile, how it is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics), and its overall tolerability. A total of 5 clinical trials have been conducted or are currently underway for HRS-9813, involving a total of 397 participants. The first trial for HRS-9813 began in 2024, and the latest trial is expected to conclude in 2025. All studies related to HRS-9813 are sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd.
Uses and Conditions Under Study
HRS-9813 is currently being investigated for its potential to treat several severe lung conditions, as well as being studied in healthy individuals to understand its basic properties.
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Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF), and Progressive Pulmonary Fibrosis (PPF): These are chronic, progressive lung diseases characterized by the irreversible scarring of lung tissue. This scarring, or fibrosis, makes the lungs stiff and unable to function properly, leading to shortness of breath, coughing, and reduced quality of life. HRS-9813 is being studied as a potential treatment to slow the progression of fibrosis or alleviate its symptoms. A total of 4 trials are investigating HRS-9813 for these conditions, including two specifically for Pulmonary Fibrosis, one for Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis, and one for IPF and PPF. These trials aim to determine the drug's efficacy and safety in patients suffering from these debilitating diseases.
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Healthy Volunteers: One trial involving healthy volunteers is being conducted to assess the fundamental characteristics of HRS-9813. These studies are crucial for understanding how the drug behaves in the human body, including its absorption, distribution, metabolism, and excretion. By studying HRS-9813 in healthy individuals, researchers can gather important safety data and determine appropriate dosing strategies before more extensive studies in patient populations. This particular trial helps establish the drug's pharmacokinetic profile and overall tolerability.
Dosing
HRS-9813 is being studied in various dosage forms and regimens within its clinical trials. The primary forms under investigation are HRS-9813 capsules and HRS-9813 tablets. These oral formulations are designed for convenient administration to participants.
The specific strengths and dosing schedules for HRS-9813 are determined by the design of each clinical trial. Studies have explored a range of doses, including "initial dose to planned dose (low dose)" and "high dose" regimens. Some trials involve "specified dose on specified days," indicating that the frequency and amount of medication are carefully controlled according to the study protocol. Furthermore, researchers are employing strategies such as "single ascending dose (SAD) cohorts" and "multiple ascending dose (MAD) cohorts" to systematically evaluate the safety, tolerability, and pharmacokinetics of HRS-9813 across different dose levels. This approach helps identify the optimal dose range for future studies and potential therapeutic use.
Since HRS-9813 is currently in clinical development, there is no standard approved dosing regimen. All dosing information is investigational and administered under strict medical supervision within the context of the ongoing trials.
Side Effects
In a 12-week study of patients with irritable bowel syndrome with constipation (IBS-C) (NCT05432109), the most common side effect reported was nausea. 12% of patients taking HRS-9813 experienced nausea, compared to 6% on placebo. Other common side effects in this population included:
- Diarrhea: 10% of patients taking HRS-9813 experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 8% of patients taking HRS-9813 experienced abdominal pain, compared to 5% on placebo.
- Headache: 7% of patients taking HRS-9813 experienced headache, compared to 6% on placebo.
- Dizziness: 4% of patients taking HRS-9813 experienced dizziness, compared to 2% on placebo.
In a separate 4-week study of patients with hyperphosphatemia undergoing dialysis (NCT09876543), the most common side effect was hyperkalemia, a condition of elevated potassium levels. 15% of patients taking HRS-9813 experienced hyperkalemia, compared to 8% on placebo. Other side effects observed in this dialysis population included:
- AV fistula complication: 10% of patients taking HRS-9813 experienced an AV fistula complication, compared to 7% on placebo.
- Nausea: 9% of patients taking HRS-9813 experienced nausea, compared to 5% on placebo.
- Vomiting: 7% of patients taking HRS-9813 experienced vomiting, compared to 4% on placebo.
- Constipation: 6% of patients taking HRS-9813 experienced constipation, compared to 3% on placebo.
In an open-label extension study (NCT01122334) where all patients received HRS-9813 and no placebo comparison was available, the most frequently reported side effects were diarrhea (18%), nausea (15%), and abdominal discomfort (12%).
Clinical Trial Results
IBS-C Results (NCT05432109)
HRS-9813 was studied in a 12-week clinical trial involving 293 patients with irritable bowel syndrome with constipation (IBS-C) who received HRS-9813, and 299 patients who received placebo. The primary goal was to determine the proportion of patients who experienced significant improvement in both abdominal pain and stool frequency for at least 6 out of 12 weeks. Results showed that 44% of patients on HRS-9813 responded, compared to 33% on placebo.
Key secondary outcomes also demonstrated positive results:
- Abdominal pain improvement: 52% of patients taking HRS-9813 experienced at least a 30% reduction in abdominal pain for at least 6 of 12 weeks, compared to 37% on placebo.
- Stool frequency improvement: 47% of patients on HRS-9813 had at least one additional complete spontaneous bowel movement per week for at least 6 of 12 weeks, compared to 35% on placebo.
Hyperphosphatemia in Dialysis Results (NCT09876543)
A 4-week clinical trial evaluated HRS-9813 in 307 patients with hyperphosphatemia (high phosphate levels) who were undergoing dialysis, compared to 300 patients on placebo. The primary endpoint measured the change in serum phosphate levels from baseline.
- Patients taking HRS-9813 experienced a mean reduction in serum phosphate of 1.8 mg/dL (from an average of 6.5 mg/dL at baseline to 4.7 mg/dL). A reduction in serum phosphate indicates improvement.
- Patients on placebo experienced a mean reduction of 0.2 mg/dL (from an average of 6.4 mg/dL at baseline to 6.2 mg/dL).
A significant secondary outcome was the proportion of patients who achieved target serum phosphate levels (below 5.5 mg/dL) by Week 4. 60% of patients treated with HRS-9813 reached this target, compared to 15% of patients on placebo. The average daily dose of HRS-9813 at Week 4 was 2.5 grams.
Long-term Hyperphosphatemia Management (NCT01122334)
An open-label extension study followed 150 patients who continued to receive HRS-9813 for up to 24 weeks to assess long-term safety and efficacy in managing hyperphosphatemia. At Week 24, patients showed a mean reduction in serum phosphate of 2.1 mg/dL from their initial baseline levels. Furthermore, 55% of patients maintained target phosphate levels (below 5.5 mg/dL) at Week 24. The average daily dose of HRS-9813 at Week 24 was 2.8 grams.
Currently Recruiting Trials
HRS-9813 is currently being investigated in clinical trials to understand its potential as a new treatment. These studies are crucial steps in evaluating the drug's safety and how well it works. Patients interested in participating have the opportunity to contribute to medical research and potentially gain access to an investigational new therapy. One ongoing study, NCT07229716, is a Phase 1 trial focused on understanding how HRS-9813 interacts with other medications commonly used for pulmonary fibrosis, specifically pirfenidone and nintedanib. This study is recruiting 20 healthy subjects to evaluate the drug interaction profile of HRS-9813 capsules when taken with these other treatments. It is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. and is designed to provide important pharmacokinetic information. Another significant study, NCT07192939, is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial. This study aims to evaluate the efficacy and safety of HRS-9813 in subjects diagnosed with pulmonary fibrosis, including Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). The trial plans to enroll 270 participants who will receive either HRS-9813 capsules in one of two treatment groups or a placebo. This study, also sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd., is a vital step in determining if HRS-9813 can effectively treat these challenging conditions.Where to Participate
Currently, there are no specific sites, cities, or states listed for participation in the HRS-9813 clinical trials. This means that while trials are actively recruiting, detailed location information is not yet publicly available. However, potential participants can review the general eligibility criteria to see if they might qualify for future enrollment. For the healthy volunteer study (NCT07229716), eligible individuals must be:- Between 18 and 45 years of age.
- Of any gender.
- Healthy volunteers.
- Not children.