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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Focal Segmental Glomerulosclerosis; IgA Nephropathy
• Intervention / Treatment: Drug: HS-10390 tablet; Drug: Placebo tablet

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bicheng Liu; Phone Number: 18001580838; Email: liubc64@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda Hospital, Affiliated to Southeast University
      • Contact: Ren Zhou; Phone Number: 025-83272015; Email: zdll2015@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): February 16, 2024
• Study Completion (Estimated): February 16, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Pharmacodynamics; HS-10390
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulosclerosis, Focal Segmental; Glomerulonephritis, IGA
• Other Study ID Numbers: HS-10390-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No