BridgeMD
New treatment option for Diabetes Mellitus
Official title A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
ClinicalTrials.gov ID: NCT07540754
What this study is testing
What is HRS9531 Injection?
HRS9531 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetes mellitus.
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
- This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.
- 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
- Participants must fully understand and voluntarily sign a written informed consent form before the trial, demonstrating comprehension of the trial...
- Female participants of childbearing potential must have a negative baseline serum pregnancy test, must not be lactating, and must agree to use...
- Aged 18 to 65 years (inclusive), both male and female.
- Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) is within the range of 19.0 to...
You likely can't join if
- Participation in any clinical trial of a drug or medical device within 3 months prior to dosing, or currently within the follow-up period of a...
- Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or...
- Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.
- Drug abusers or those with a positive urine drug screening test.
- Blood loss or blood donation ≥400 mL within 3 months prior to dosing, or blood loss or blood donation ≥ 200 mL within 1 month prior to dosing, or...
- Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.
See the full eligibility criteria
- Participants must fully understand and voluntarily sign a written informed consent form before the trial, demonstrating comprehension of the trial content, procedures, and potential adverse reactions; they must also be...
- Female participants of childbearing potential must have a negative baseline serum pregnancy test, must not be lactating, and must agree to use contraceptive measures and refrain from egg donation from the time of...
- Aged 18 to 65 years (inclusive), both male and female.
- Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) is within the range of 19.0 to 40.0 kg/m² (inclusive).
- Participation in any clinical trial of a drug or medical device within 3 months prior to dosing, or currently within the follow-up period of a clinical study or within 5 half-lives of the investigational drug (whichever...
- Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.
- Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.
- Drug abusers or those with a positive urine drug screening test.
- Blood loss or blood donation ≥400 mL within 3 months prior to dosing, or blood loss or blood donation ≥ 200 mL within 1 month prior to dosing, or receipt of a blood transfusion within 3 months prior to dosing.
- Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.
- Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical...
- History of severe hypoglycemia.
- Previous significant gastric emptying abnormalities or factors affecting gastric emptying (e.g., history of gastric bypass surgery, pyloric stenosis), or severe gastrointestinal diseases (e.g., active peptic ulcer...
- Anyone with factors making them unsuitable to participate in this trial evaluated by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, 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 Zhengzhou, Henan, 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.