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

Sponsor

Hansoh BioMedical R&D Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05942625

Collaborator

(none)

Enrollment

Location

Arms

8.8

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IgA Nephropathy Focal Segmental Glomerulosclerosis	Drug: HS-10390 tablet Drug: Placebo tablet	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 23, 2023

Anticipated Primary Completion Date :

Feb 16, 2024

Anticipated Study Completion Date :

Feb 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HS-10390 Single or multiple dosing of HS-10390 in a fastingstate	Drug: HS-10390 tablet Oral administration of specified dose of HS-10390
Experimental: Placebo Single or multiple dosing of placebo in a fastingstate	Drug: Placebo tablet Oral administration of matching dose ofplacebo

Arm

Intervention/Treatment

Experimental: HS-10390

Single or multiple dosing of HS-10390 in a fastingstate

Drug: HS-10390 tablet

Oral administration of specified dose of HS-10390

Experimental: Placebo

Single or multiple dosing of placebo in a fastingstate

Drug: Placebo tablet

Oral administration of matching dose ofplacebo

Outcome Measures

Primary Outcome Measures

Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation [Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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