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

September 5, 2023 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital Affiliated to Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy male or female subjects between the ages of 18-45 years
  2. 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
  3. Have signed the informed consent form approved by the IRB

Exclusion Criteria:

  1. 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
  2. Have a history of or current allergic disease
  3. Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
  4. Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
  5. Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
  6. Pregnant or breastfeeding female subjects
  7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HS-10374
Single and multiple ascending doses of HS-10374 orally
Drug: HS-10374 tablets
Single or multiple dosing of HS-10374 orally in a fasting state
Placebo Comparator: Placebo
Single and multiple ascending doses of HS-10374-matched placebo orally
Drug: HS-10374-matched placebo tablets
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with clinical laboratory abnormalities
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of vital signs
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of physical examination
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Maximum plasma concentration
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Tmax
Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Time to reach Cmax
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
AUC
Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Area under the plasma concentration-time curve
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
t½
Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Terminal half-life
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
CL/F
Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent clearance
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Vz/F
Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent volume of distribution
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Rac
Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Accumulation ratio
Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing Zhang, PhD, Huashan Hospital
  • Principal Investigator: Jinhua Xu, MD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-10374-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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