Status:
RECRUITING
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
IgA Nephropathy
Focal Segmental Glomerulosclerosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 t...
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
Key Trial Info
Start Date :
May 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05942625
Start Date
May 23 2023
End Date
December 30 2024
Last Update
October 9 2024
Active Locations (1)
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1
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China