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

Phase 1

Recruiting

• Conditions: IgA Nephropathy; Focal Segmental Glomerulosclerosis
• Interventions: Drug: Placebo tablet; Drug: HS-10390 tablet

• Registration Number: NCT05942625
• Lead Sponsor: Hansoh BioMedical R&D Company

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 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 Timeline

• Study Start: 2023-05-23
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Primary Completion: 2024-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo tablet	Single or multiple dosing of placebo in a fastingstate
HS-10390	HS-10390 tablet	Single or multiple dosing of HS-10390 in a fastingstate

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Apparent volume of distribution (Vz/F)	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)
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)
Half time (t½)	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)
Accumulation ratio（Rac）	Day 14 up to Day 19 (MAD)

Trial Locations

Locations (1)

Zhongda Hospital, Affiliated to Southeast University; 🇨🇳 Nanjing, Jiangsu, China