A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects

What this Trial Is About

Researchers are studying the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10390 in healthy adults aged 18 to 45 years. This Phase 1 trial aims to understand how the drug behaves in the body and how well it is tolerated when taken in different doses. The study specifically involves healthy volunteers to gather initial data before testing in patients with conditions like IgA Nephropathy or Focal Segmental Glomerulosclerosis. The study uses a randomized, double-blind, placebo-controlled design with single and multiple ascending dose (SAD and MAD) periods. There will be about six sequential groups for single doses and three for multiple doses. Participants will receive oral tablets of HS-10390 or a matching placebo while fasting. The multiple dose phase begins after safety and PK data from the single dose phase are reviewed. A sentinel dosing approach is used in the first single dose group to enhance safety. Participants will be monitored from Day 1 up to Day 12 for single doses and up to Day 28 for multiple doses. Researchers will assess adverse events, serious adverse events, and any events leading to stopping the study drug. They will also measure drug levels in the blood over time to understand how quickly and extensively the drug is absorbed, distributed, and cleared. Safety checks include physical exams, lab tests, vital signs, ECGs, and imaging as needed. The total study duration varies by participant depending on the dosing schedule and monitoring requirements.

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