Status:

RECRUITING

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

Lead Sponsor:

Hansoh BioMedical R&D Company

Conditions:

IgA Nephropathy

Focal Segmental Glomerulosclerosis

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

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 t...

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

Key Trial Info

Start Date :

May 23 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2024

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT05942625

Start Date

May 23 2023

End Date

December 30 2024

Last Update

October 9 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, China