RecruitingPhase 1NCT05942625

A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

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


Sponsor

Hansoh BioMedical R&D Company

Enrollment

84 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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

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Interventions

DRUGHS-10390 tablet

Oral administration of specified dose of HS-10390

DRUGPlacebo tablet

Oral administration of matching dose ofplacebo


Locations(1)

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, China

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NCT05942625


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