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New treatment option for Hyperlipidemias
Official title A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function
ClinicalTrials.gov ID: NCT07322016
What this study is testing
What is HRS-1301 Tablet?
HRS-1301 Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hyperlipidemias.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
- Male or female people aged 18 to 65 (including 18 and 65);
- Body mass index (BMI) ranges from 18 kg/m2 to 30 kg/m2 (including 18 and 30),and Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg;
- The glomerular filtration rate should meet the following criteria (GFR, mL/min): people with mild renal impairment: 60-89 mL/min; people with...
You likely can't join if
- Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those...
- Those with cardiogenic shock, severe conduction obstruction, sick sinus syndrome, heart failure (NYHA grade III-IV), persistent rapid arrhythmia...
- Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding skin non-melanomas that have...
- Those with a history of gastric or intestinal surgery that some researchers believe may affect drug absorption;
- Those who have suffered severe trauma or undergone major surgical operations within the three months prior to screening, or who plan to undergo...
- Those who have participated in any clinical trials of drugs or medical devices within three months prior to screening, or those who are still within...
See the full eligibility criteria
- Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
- Male or female people aged 18 to 65 (including 18 and 65);
- Body mass index (BMI) ranges from 18 kg/m2 to 30 kg/m2 (including 18 and 30),and Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg;
- The glomerular filtration rate should meet the following criteria (GFR, mL/min): people with mild renal impairment: 60-89 mL/min; people with moderate renal impairment: 30-59 mL/min; people with severe renal function...
- Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those allergic to any drug or food), or those known to be allergic to any...
- Those with cardiogenic shock, severe conduction obstruction, sick sinus syndrome, heart failure (NYHA grade III-IV), persistent rapid arrhythmia, tortuous ventricular tachycardia or ventricular tachycardia at the...
- Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding skin non-melanomas that have been treated without recurrence signs and resected cervical...
- Those with a history of gastric or intestinal surgery that some researchers believe may affect drug absorption;
- Those who have suffered severe trauma or undergone major surgical operations within the three months prior to screening, or who plan to undergo surgery during the trial period;
- Those who have participated in any clinical trials of drugs or medical devices within three months prior to screening, or those who are still within five half-lives of the drug before screening (whichever is longer);
- Those who have donated blood of ≥ 400 mL within 4 weeks before screening, or have suffered severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 8 weeks;
- Those who received live (attenuated) vaccines within 4 weeks prior to screening or those who plan to receive them during the trial;
- Those with potential difficulties in blood collection and a history of fainting at the sight of needles or blood;
- For patients with renal insufficiency,those who have received renal replacement therapy (such as peritoneal dialysis, hemodialysis, etc.) within 3 months prior to the screening or during the expected trial period;
- For patients with renal insufficiency，screening individuals with underlying diseases that induce chronic kidney disease within the previous three months and are judged by researchers to be poorly controlled, such as...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.