Lipoprotein Disorder
Conditions
Brief summary
This study is a single center, randomized, open label crossover trial planned to include 50 healthy participants to evaluate the relative bioavailability of HRS-5346 new and old formulations in healthy participants. The experimental process includes three stages: screening period, baseline period, and administration observation period.
Interventions
DRUGHRS-5346
Dose A, Dose B
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntary signing of ICF prior to trial initiation; full understanding of trial content, procedures, and potential AEs; willingness to strictly adhere to the protocol and complete the trial. 2. Age 18-45 years (inclusive) on ICF signing date; male or female. 3. Body weight ≥ 50 kg (male) or ≥ 45 kg (female); BMI between 19 and 28 kg/m² (inclusive). 4. No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray (or CT), per investigator assessment; QTcF ≤ 450 ms (male) or ≤ 470 ms (female) on 12-lead ECG. 5. Willingness to use effective contraception (participants and partners) from ICF signing to 2 weeks post-last dose; negative serum pregnancy test and non-lactating status for female participants.
Exclusion criteria
1. Those with any clinically serious diseases judged by the investigator involving the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or other diseases or medical histories that may interfere with the trial results; 2. Those with malignant tumors, or a history of malignant tumors within 5 years before screening (except for non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia); 3. Those who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before screening, or who are still within 5 half-lives of the above drugs at the time of screening (whichever is longer); 4. Those who plan to take medications other than the trial drug during the trial period; 5. Those who have participated in any clinical trial of drugs or medical devices within 3 months before screening (participation in a clinical trial is defined as: having given informed consent for a clinical trial and having used the trial drug (including placebo) or trial medical device), and who are still within the follow-up period of a clinical study or within 5 half-lives of the trial drug at the time of screening (whichever is longer); 6. Those with a suspected history of allergy to the study drug or any component of the study drug, those with allergic constitution, or those with a history of severe drug allergy; 7. Those with a previous history of difficulty in blood collection or inability to tolerate venipuncture, such as those with needle phobia or blood phobia; 8. Those with a previous history of gastric or intestinal surgery that, in the investigator's opinion, may affect drug absorption, or those with gastrointestinal diseases that may affect drug absorption; 9. Those who have had a severe infection, severe trauma, or major surgery within 3 months before screening; or those who plan to undergo surgery during the trial period or within two weeks after its completion; 10. Those who have donated blood or experienced blood loss of ≥ 200 mL in total within 1 month before screening, or ≥ 400 mL in total within 3 months before screening, or those who have received a blood transfusion within 8 weeks; 11. Those who have smoked an average of ≥ 5 cigarettes per day within 3 months before screening; those who have consumed an average of more than 15 g of alcohol per day within 1 month before screening (5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, approximately 17 mL of low-alcohol liquor, or 10 mL of high-alcohol liquor), or those who refuse to abstain from smoking, alcohol, and caffeinated foods or beverages during the screening period and the trial period, as well as those with special dietary requirements who cannot adhere to a unified diet; 12. Those who, from 48 hours before taking the study drug until the end of the study, refuse to discontinue any beverages containing methylxanthines, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any fruit juices, refuse to refrain from vigorous exercise, or have other factors that may affect drug absorption, distribution, metabolism, or excretion; 13. Those with a high-sensitivity C-reactive protein level \> 1.5 times the upper limit of normal, or prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time (APTT) \> 1.25 times the upper limit of normal during the screening period; 14. Those who test positive in the infectious disease screening during the screening period (including hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis antibody); 15. Those who have received a vaccination within 1 month before screening or plan to receive a vaccination during the trial or within 1 month after dosing; 16. Women who are pregnant or lactating at the screening and baseline visits; 17. Those who test positive in the alcohol breath test at the baseline visit; 18. Those with a history of drug abuse or substance abuse; or those who test positive in the urine drug test at the screening and baseline visits; 19. Staff of the research center or other personnel directly involved in the execution of the protocol; 20. Other conditions that, in the investigator's opinion, make the participant unsuitable for participation in this trial, such as physiological or psychological diseases or conditions that may increase the risk of the trial, affect the participant's compliance with the protocol, or affect the participant's ability to complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | From before administration to one month after administration |
| AUC0-t | From before administration to one month after administration |
| AUC0-inf | From before administration to one month after administration |
Secondary
| Measure | Time frame |
|---|---|
| Tmax | From before administration to one month after administration |
| CL/F | From before administration to one month after administration |
| Vz/F | From before administration to one month after administration |
| t1/2 | From before administration to one month after administration |
| Adverse event | From before administration to one month after administration |
Countries
China
Contacts
CONTACTWeijie Kong
CONTACTYanli Dong
Outcome results
None listed