search
Back to results

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

Primary Purpose

IgA Nephropathy, Focal Segmental Glomerulosclerosis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HS-10390 tablet
Placebo tablet
Sponsored by
Hansoh BioMedical R&D Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring HS-10390, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Zhongda Hospital, Affiliated to Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HS-10390

Placebo

Arm Description

Single or multiple dosing of HS-10390 in a fastingstate

Single or multiple dosing of placebo in a fastingstate

Outcomes

Primary Outcome Measures

Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation

Secondary Outcome Measures

Maximum plasma concentration (Cmax)
Time to reach Cmax (Tmax)
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Half time (t½)
Apparent clearance (CL/F)
Apparent volume of distribution (Vz/F)
Accumulation ratio(Rac)

Full Information

First Posted
July 4, 2023
Last Updated
July 12, 2023
Sponsor
Hansoh BioMedical R&D Company
search

1. Study Identification

Unique Protocol Identification Number
NCT05942625
Brief Title
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
February 16, 2024 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hansoh BioMedical R&D Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy, Focal Segmental Glomerulosclerosis
Keywords
HS-10390, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HS-10390
Arm Type
Experimental
Arm Description
Single or multiple dosing of HS-10390 in a fastingstate
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Single or multiple dosing of placebo in a fastingstate
Intervention Type
Drug
Intervention Name(s)
HS-10390 tablet
Intervention Description
Oral administration of specified dose of HS-10390
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
Oral administration of matching dose ofplacebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Maximum plasma concentration (Cmax)
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Time to reach Cmax (Tmax)
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
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)
Title
Half time (t½)
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Apparent clearance (CL/F)
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Apparent volume of distribution (Vz/F)
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Accumulation ratio(Rac)
Time Frame
Day 14 up to Day 19 (MAD)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bicheng Liu
Phone
18001580838
Email
liubc64@163.com
Facility Information:
Facility Name
Zhongda Hospital, Affiliated to Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren Zhou
Phone
025-83272015
Email
zdll2015@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs