A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- HS-10390 tablet
- Conditions
- IgA Nephropathy
- Sponsor
- Hansoh BioMedical R&D Company
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
HS-10390
Single or multiple dosing of HS-10390 in a fastingstate
Intervention: HS-10390 tablet
Placebo
Single or multiple dosing of placebo in a fastingstate
Intervention: Placebo tablet
Outcomes
Primary Outcomes
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
Secondary Outcomes
- Apparent volume of distribution (Vz/F)(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Apparent clearance (CL/F)(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))
- Time to reach Cmax (Tmax)(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))
- 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))
- Accumulation ratio（Rac）(Day 14 up to Day 19 (MAD))