About this trial
The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:
* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen? * What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males or females aged 18-65 years (inclusive), with a body mass index (BMI) between 18.00 and 32.00 kg/m2(inclusive);
Not participated in any other clinical trials within the past 30 days or 5 half-lives of other investigational drugs prior to the screening, whichever is longer;
For women of reproductive potential, a negative pregnancy test is required, and they must agree to use contraception (more details see Appendix 1) from the time of signing the informed consent form until at least 90 days after the last dose of investigational product. Male subjects must agree to use adequate contraception from the time of signing the informed consent form until at least 90 days after the last dose of investigational product, and donation of sperm or ova is prohibited during the entire study period;
In good health, determined by the investigator on the basis of medical history, physical examinations, vital signs, 12-lead electrocardiograms (12-ECGs), clinical laboratory tests (haematology, urinalysis, blood chemistry). Repeated examination is allowed once at investigator's discretion;
Disqualifiers
Individuals who are allergic to the investigational product or any of its components, or who are easily allergic at investigator's discretion;
Individuals who are intolerant to venipuncture/venous catheterization or blood fainting or needle phobia;
Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) during the screening period;
Average daily smoking of more than 5 cigarettes in the 3 months prior to screening, or inability to stop using any tobacco products (including nicotine products) during the trial;
Trial design
Sequential
Treatments tested in this trial
Placebo
DrugNS-136 matching placebo
NS-136 tablet
DrugInvestigational product NS-136
Treatment groups
14
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Number of Participants with Treatment-Related Adverse Events
Main pharmacokinetic parameters
Vd/F
Main pharmacokinetic parameters
CL/F
Main pharmacokinetic parameters
t1/2
Sponsors and contacts
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