Focal Segmental Glomerulosclerosis, IgA Nephropathy
Conditions
Keywords
HS-10390, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
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 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.
Interventions
DRUGHS-10390 tablet
Oral administration of specified dose of HS-10390
DRUGPlacebo tablet
Oral administration of matching dose ofplacebo
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation | Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD) |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax (Tmax) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Half time (t½) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Maximum plasma concentration (Cmax) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Apparent volume of distribution (Vz/F) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Accumulation ratio（Rac） | Day 14 up to Day 19 (MAD) |
| Apparent clearance (CL/F) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
Countries
China
Contacts
Primary ContactBicheng Liu
Outcome results
None listed