Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study a new oral medication called HS-10398. The researchers want to understand how safe it is, how the body processes it, and how food affects its absorption. The trial will involve healthy volunteers and individuals with kidney dysfunction. Healthy participants will help scientists learn about the medication's effects in people without any health issues, while those with kidney problems will provide insights on how the drug works in their bodies.

To be eligible for this trial, participants should be between 18 and 64 years old, and healthy individuals need to weigh at least 50 kg (around 110 lbs for men) or 45 kg (about 99 lbs for women). Additionally, participants must be fully informed about the study and give their consent to take part. Those with kidney dysfunction must have specific kidney health criteria. Throughout the trial, participants will be closely monitored for any side effects, and they will need to follow certain guidelines, such as not taking other medications that could interfere with the study. Overall, those who join this trial will contribute to important research that could help improve treatments for various conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy participants aged from 18 to 64 years
• • Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
• • Males' weight should be ≥ 50kg, and females' weight should be ≥ 45kg. Body mass index (BMI), calculated as weight/height\^2 (kg/m\^2), should be controlled within the range of 19 to 28, including the critical value
• • Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration
• • Participants with Kidney Dysfunction must have met the following additional criteria to be enrolled in this study：Patients with chronic kidney disease (defined as the presence of any markers of kidney damage or an estimated glomerular filtration rate (eGFR) persistently less than 90 mL/min/1.73m² for more than 3 months), and with an estimated glomerular filtration rate (eGFR) at screening and baseline assessments (with a minimum interval of 3 days between screening and baseline assessments) meeting the criteria of 60≤eGFR\<90 mL/min/1.73m².
• Exclusion Criteria:
• • Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
• • Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4/5 or CYP2C8 or any medications that inhibit P-glycoprotein transporters., within 2 weeks (or 5 half-lives) before screening and throughout the study period
• • Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), \>450 ms (males), \>470 ms (females)
• • Has participated in another clinical trial involving drugs or medical devices within the month prior to screening and received investigational drugs or used medical devices, or within 5 half-lives of the investigational drugs from another trial at the time of screening, whichever is longer
• • Unable to abstain from smoking and alcohol.
• • History of drug dependence or substance abuse