A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 in Healthy Subjects

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HRS-1301, which is being tested to see how safe it is and how the body processes it in healthy adults. The trial is focused on understanding how the medication affects cholesterol levels, which is important for managing conditions like hyperlipidemia (high cholesterol). There are two parts to the study, and they plan to enroll up to 82 healthy participants between the ages of 18 and 55.

To participate, you must be in good health and not be pregnant or planning to become pregnant. You'll need to understand the study procedures and willingly agree to take part in the trial. Participants will take the medication either once or multiple times, and the researchers will monitor their health closely throughout the study. It’s important to note that people with certain medical conditions or recent surgeries, as well as those who have taken specific medications or vaccines, may not be eligible to join. This trial is currently looking for volunteers, so if you meet the criteria and are interested, it could be a great opportunity to contribute to medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male and female subjects must be at least 18 years old and no more than 55 years old on the date of signing the ICF.
• • 2. The female subjects must be non-pregnant or non-childbearing potential.
• • 3. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.
• Exclusion Criteria:
• • 1. Have a gastrointestinal, liver or kidney disease or other condition known to affect drug absorption, distribution, metabolism and excretion or to reduce adherence, as determined by the investigator.
• • 2. Those who had severe trauma or had undergone surgery within 3 months prior to screening, or planned to undergo surgery during the trial.
• • 3. Have a history of repeated drug allergies.
• • 4. People who have used any drug in the 2 weeks prior to screening.
• • 5. Those who received live (attenuated) vaccine within 4 weeks prior to screening or planned to receive it during the trial.