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A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HS-10374 tablets
HS-10374-matched placebo tablets
Sponsored by
Jiangsu Hansoh Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

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 of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing Have signed the informed consent form approved by the IRB Exclusion Criteria: Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, 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 or drugs of abuse Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests Pregnant or breastfeeding female subjects Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period

Sites / Locations

  • Huashan Hospital Affiliated to Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HS-10374

Placebo

Arm Description

Single and multiple ascending doses of HS-10374 orally

Single and multiple ascending doses of HS-10374-matched placebo orally

Outcomes

Primary Outcome Measures

Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Number of participants with clinical laboratory abnormalities
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Number of participants with abnormalities of vital signs
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Number of participants with abnormalities of physical examination
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Number of participants with abnormalities of electrocardiogram (ECG) parameters
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.

Secondary Outcome Measures

Cmax
Maximum plasma concentration
Tmax
Time to reach Cmax
AUC
Area under the plasma concentration-time curve
Terminal half-life
CL/F
Apparent clearance
Vz/F
Apparent volume of distribution
Rac
Accumulation ratio

Full Information

First Posted
August 24, 2023
Last Updated
September 5, 2023
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06033742
Brief Title
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 13, 2021 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
HS-10374
Arm Type
Experimental
Arm Description
Single and multiple ascending doses of HS-10374 orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single and multiple ascending doses of HS-10374-matched placebo orally
Intervention Type
Drug
Intervention Name(s)
HS-10374 tablets
Intervention Description
Single or multiple dosing of HS-10374 orally in a fasting state
Intervention Type
Drug
Intervention Name(s)
HS-10374-matched placebo tablets
Intervention Description
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state
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 42 (MAD)
Title
Number of participants with clinical laboratory abnormalities
Description
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Time Frame
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Title
Number of participants with abnormalities of vital signs
Description
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Time Frame
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Title
Number of participants with abnormalities of physical examination
Description
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Time Frame
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Title
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Description
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Time Frame
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum plasma concentration
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Tmax
Description
Time to reach Cmax
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
AUC
Description
Area under the plasma concentration-time curve
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Description
Terminal half-life
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
CL/F
Description
Apparent clearance
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Vz/F
Description
Apparent volume of distribution
Time Frame
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Title
Rac
Description
Accumulation ratio
Time Frame
Day 1 up to Day 6 (SAD), Day 1 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 of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing Have signed the informed consent form approved by the IRB Exclusion Criteria: Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, 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 or drugs of abuse Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests Pregnant or breastfeeding female subjects Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Zhang, PhD
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinhua Xu, MD
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

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A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects

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