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

Last updated: October 7, 2024
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Recruiting

Phase

1

Condition

Nephrotic Syndrome

Glomerulonephritis

Focal Segmental Glomerulosclerosis

Treatment

HS-10390 tablet

Placebo tablet

Clinical Study ID

NCT05942625
HS-10390-101
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 methodofcontraception, and refrain from donating sperm or eggs during the study period andforat least 6 months after last dosing

  • Have signed the informed consent form approved by the IRB

Exclusion

Exclusion Criteria:

  • History or evidence of clinically significant cardiovascular, pulmonary,endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolicdiseases, especiallythose conditions that interfere with absorption, metabolismand/or excretion of the studydrug, determined by the investigator

  • Have a clinically significant infection currently or within past 30 days, or have ahistory ofactive tuberculosis; or have positive screening test for infectiousdisease, 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) foralcohol ordrugs of abuse

  • Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive testresultfor nicotine

  • Clinically significant abnormal physical examination, vital signs, clinicallaboratory values,ECGs or imaging tests

  • Pregnant or breastfeeding female subjects

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: HS-10390 tablet
Phase: 1
Study Start date:
May 23, 2023
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

  • Zhongda Hospital, Affiliated to Southeast University

    Nanjing, Jiangsu
    China

    Active - Recruiting

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