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Completed

NCT Number: NCT06033742

A First in Human Study to Evaluate Safety, Tolerability, Pharmacology 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HS-10374 tablets

Drug

Single or multiple dosing of HS-10374 orally in a fasting state

HS-10374-matched placebo tablets

Drug

Single or multiple dosing of HS-10374-matched placebo orally in a fasting state

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Cmax

    Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

    Maximum plasma concentration

  2. Tmax

    Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

    Time to reach Cmax

  3. AUC

    Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

    Area under the plasma concentration-time curve

  4. Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

    Terminal half-life

  5. CL/F

    Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

    Apparent clearance

  6. Vz/F

    Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

    Apparent volume of distribution

  7. Rac

    Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

    Accumulation ratio

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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