A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHansoh BioMedical R&D Company
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HS-10390 tablet
- Placebo tablet
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov