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

Hansoh Pharma

Status and phase: Enrolling; Phase 1

Conditions: Focal Segmental Glomerulosclerosis; IgA Nephropathy

Treatments: Drug: Placebo tablet; Drug: HS-10390 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05942625

HS-10390-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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84 participants in 2 patient groups

HS-10390

Experimental group

Description:

Single or multiple dosing of HS-10390 in a fastingstate

Treatment:

Drug: HS-10390 tablet

Placebo

Experimental group

Description:

Single or multiple dosing of placebo in a fastingstate

Treatment:

Drug: Placebo tablet