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First-in-Human Study to Investigate the Safety and Tolerability and Pharmacokinetics of HS-10383

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05429723
Recruitment Status : Recruiting
First Posted : June 23, 2022
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 19, 2022
First Posted Date  ICMJE June 23, 2022
Last Update Posted Date July 1, 2022
Actual Study Start Date  ICMJE March 1, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2022)
Safety and Tolerability Evaluation [ Time Frame: up to 9 days ]
  1. Adverse events (AEs), serious adverse events (SAEs) and adverse events leading to withdrawal from the study, the incidence, severity and correlation with the trial drug;
  2. Changes in laboratory tests (blood routine, urine routine, blood biochemistry and coagulation function) before and after administration;
  3. Changes in vital signs (respiration, pulse, blood pressure and body temperature) and SpO2 before and after administration;
  4. Electrocardiogram (ECG) to check the changes before and after administration.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2022)
  • Maximum plasma concentration (Cmax) [ Time Frame: up to 9 days ]
    To assess Cmax of single ascending oral doses of HS-10383
  • Time of Maximum Concentration [ Time Frame: up to 9 days ]
    To assess Tmax of single ascending oral doses of HS-10383
  • Terminal Rate Constant [ Time Frame: up to 9 days ]
    To assess λz of single ascending oral doses of HS-10383
  • Elimination Halflife [ Time Frame: up to 9 days ]
    To assess λz of single ascending oral doses of HS-10383
  • Area Under the Concentration-time Curve0-t [ Time Frame: up to 9 days ]
    To assess Curve0-t of single ascending oral dosCurve0-tes of HS-10383
  • Area Under the Concentration-time Curve0-∞ [ Time Frame: up to 9 days ]
    To assess AUC0-∞ of single ascending oral doses of HS-10383
  • Clearance Rate [ Time Frame: up to 9 days ]
    To assess Clearance Rate of single ascending oral doses of HS-10383
  • Apparent Volume of Distribution [ Time Frame: up to 9 days ]
    To assess Vd/F of single ascending oral doses of HS-10383
  • Mean Retention Time [ Time Frame: up to 9 days ]
    To assess MRT of single ascending oral doses of HS-10383
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Study to Investigate the Safety and Tolerability and Pharmacokinetics of HS-10383
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Phase I Study to Assess, Safety, Tolerability, Pharmacokinetics of HS-10383 Administered Orally in China Healthy Adult Subjects
Brief Summary

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of HS-10383 using a randomized, double blind, placebo controlled, single center study design.

Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be one single dose of study drug/placebo received on only one day. The total study duration for each participant will be usually no more than 10 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Detailed Description HS-10383 is a selective P2X3 receptor antagonist being developed for the treatment of refractory/unexplained chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single doses of HS-10383 administered orally to healthy volunteers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cough
Intervention  ICMJE
  • Drug: HS-10383
    HS-10383 administered as one 50 mg, 150 mg, 450 mg and 900 mg tablet once daily, depending upon randomization.
  • Drug: HS-10383 Placebo
    Placebo for HS-10383
Study Arms  ICMJE
  • Experimental: HS-10383
    HS-10383 was administered at 8 am on the first day, 4 dose levels
    Intervention: Drug: HS-10383
  • Placebo Comparator: HS-10383 Placebo
    Matching placebo to HS-10383 was administered at 8 am on the first day, 4 dose levels
    Intervention: Drug: HS-10383 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2022)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy participants aged from 18 to 45 years ;
  2. Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily sign the informed consent;
  3. Male weight ≥ 50kg, female weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18~26 (including the critical value);
  4. Subjects need to agree to take effective contraceptive methods from the screening date to 90 days after the last dose;
  5. Male subjects must agree not to donate sperm within 90 days from the start of the administration to the last administration.

Exclusion Criteria:

  1. The following medical histories, such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system and tumor, etc., were screened. evaluated as unsuitable to participate in this study;
  2. Any known presence or history of hypogeusia, abnormal taste or dysgeusia;
  3. Any known presence or history of severe allergies, or known to be allergic to the components of the test drug;
  4. Use of any drugs, including prescription drugs, over-the-counter drugs or herbal preparations, cannot be avoided or expected to start 2 weeks (or 5 half-lives) before screening and throughout the study period;
  5. Any findings of electrocardiogram outside from normal, such as the QT interval (QTcF) corrected by the Fridericia formula, the absolute value of QTcF for males is >450 ms, and the absolute value of QTcF for females is >470 ms;
  6. Any findings of blood pressure or pulse in resting state outside from normal a: such as systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg, pulse <55 bpm or >100 bpm;
  7. Serum creatinine exceeds the upper limit of normal (ULN) at screening;
  8. Infectious diseases with hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody test were positive at the time of screening;
  9. Any findings from the medical examination (comprehensive physical examination, vital signs, blood oxygen saturation, laboratory tests, abdominal B-ultrasound and chest X-ray ) outside from normal and deemed by the investigator to be clinically significant;
  10. Drug abusers, or have used soft drugs (such as marijuana) within 3 months prior to screening, or have taken hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before screening;
  11. Volunteers who with a positive alcohol breath test at screening, with a history of alcohol abuse or a single consumption of more than 14 units of alcohol in the past two weeks (1 unit = 285 mL of beer, 25 mL of spirits, and 150 mL of wine);
  12. Smokers or those who smoked more than 5 cigarettes per day within 3 months prior to screening, or those who could not stop using any tobacco products (including e-cigarettes) during the study;
  13. Average daily intake of coffee or tea ≥ 5 cups (200mL/cup) within 3 months prior to screening;
  14. Volunteers who donated or lost 250 mL more of blood in 3 months prior to screening, or had undergone major surgery in the past;
  15. Volunteers who participated in any clinical trials and took any clinical trial drugs within 3 months prior to screening;
  16. Difficulty swallowing solid preparations such as capsules or tablets;
  17. Within 30 days prior to screening, for whatever reason, dieting or receiving dietary therapy, or major changes in dietary habits;
  18. Within 30 days prior to screening and during the entire study period, consuming beverages or foods containing grapefruit (such as grapefruit, lime, star fruit, etc.), or products containing St. John's wort cannot be avoided;
  19. Female subjects are pregnant or breastfeeding at the screening;
  20. Females of childbearing potential with positive urine β-human chorionic gonadotropin (β-hCG) at screening, or positive serum β-hCG at baseline (day -1);
  21. Volunteers who have difficulty in blood collection and cannot tolerate multiple venous blood collection and any contraindications to blood collection;
  22. Volunteers who have a history of vaccination within 30 days prior to screening, or who have a vaccination plan throughout the study period;
  23. As determined by the investigator, any physical or psychological disease or condition that may increase the risk of the study, affect the subject's compliance with the protocol or affect the subject's completion of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wei Zhao, Doctor 15131190710 zhao4wei2@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05429723
Other Study ID Numbers  ICMJE HS-10383-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jiangsu Hansoh Pharmaceutical Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jiangsu Hansoh Pharmaceutical Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei Zhao, Doctor Qianfoshan Hospital
PRS Account Jiangsu Hansoh Pharmaceutical Co., Ltd.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP