A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

Launched by HANSOH BIOMEDICAL R&D COMPANY · Jul 4, 2023

Keywords

ClinConnect Summary

This clinical trial, called a "first in human" study, is investigating a new treatment called HS-10390 to see if it is safe and how it works in the body. The study focuses on healthy adults aged 18 to 45 who do not have any significant health problems. Participants will help researchers understand how the drug is tolerated and how it behaves in the body, which is important for developing treatments for kidney conditions like IgA Nephropathy and Focal Segmental Glomerulosclerosis.

To be eligible for the trial, individuals must be in good health, meaning they do not have serious medical conditions or infections, and they should not be pregnant or breastfeeding. Participants will be asked to follow specific guidelines, including using effective contraception and not smoking. Those who join the study will receive the new drug and will be monitored closely for any side effects or reactions. This research is a crucial step in finding new therapies for kidney diseases, and those who participate will contribute valuable information to science.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male or female subjects between the ages of 18-45 years
• • Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
• • Have signed the informed consent form approved by the IRB
• Exclusion Criteria:
• • History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator
• • Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis
• • Have a history of or current allergic disease
• • Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse
• • Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine
• • Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests
• • Pregnant or breastfeeding female subjects