Health TrialsbyHealthPanel

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

ConditionsIgA NephropathyFocal Segmental Glomerulosclerosis
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • HS-10390 tablet

    Drug

    Oral administration of specified dose of HS-10390

  • Placebo tablet

    Drug

    Oral administration of matching dose ofplacebo

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: HS-10390Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation

Time frame
Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)

Secondary outcomes

1

Maximum plasma concentration (Cmax)

Time frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
2

Time to reach Cmax (Tmax)

Time frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
3

Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

Time frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
4

Half time (t½)

Time frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov
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