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Recruiting NCT05942625

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

Phase I Interventional IgA Nephropathy Focal Segmental Glomerulosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS-10390 tablet, Placebo tablet.
Who it may be relevant to
Registry conditions: IgA Nephropathy, Focal Segmental Glomerulosclerosis. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 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.

Interventions

  • Drug HS-10390 tablet
    Oral administration of specified dose of HS-10390
  • Drug Placebo tablet
    Oral administration of matching dose ofplacebo

Primary outcome measures

  • 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 outcome measures (7)
  • Maximum plasma concentration (Cmax) [Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]
  • Time to reach Cmax (Tmax) [Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]
  • 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)]
  • Half time (t½) [Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]
  • Apparent clearance (CL/F) [Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]
  • Apparent volume of distribution (Vz/F) [Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]
  • Accumulation ratio（Rac） [Time frame: Day 14 up to Day 19 (MAD)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongda Hospital, Affiliated to Southeast University — Nanjing

Identifiers

NCT: NCT05942625 · HS-10390-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗