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Clinical Trials in China / NCT05942625
Recruiting Phase 1

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

NCT05942625 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 1
Started
2023-05-23
Last updated
2024-10-09

Condition(s) studied

IgA NephropathyFocal Segmental Glomerulosclerosis

Investigational drug(s) / intervention(s)

HS-10390 tabletPlacebo tablet

HS-10390 tablet: Oral administration of specified dose of HS-10390

Placebo tablet: Oral administration of matching dose ofplacebo

Study summary

The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongda Hospital, Affiliated to Southeast University Nanjing Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05942625 on ClinicalTrials.gov ↗ ← All trials in China