Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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.


Condition or disease Intervention/treatment Phase
Cough Drug: HS-10383 Drug: HS-10383 Placebo Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Phase I Study to Assess, Safety, Tolerability, Pharmacokinetics of HS-10383 Administered Orally in China Healthy Adult Subjects
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: HS-10383
HS-10383 was administered at 8 am on the first day, 4 dose levels
Drug: HS-10383
HS-10383 administered as one 50 mg, 150 mg, 450 mg and 900 mg tablet once daily, depending upon randomization.

Placebo Comparator: HS-10383 Placebo
Matching placebo to HS-10383 was administered at 8 am on the first day, 4 dose levels
Drug: HS-10383 Placebo
Placebo for HS-10383




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: up to 9 days ]
    To assess Cmax of single ascending oral doses of HS-10383

  2. Time of Maximum Concentration [ Time Frame: up to 9 days ]
    To assess Tmax of single ascending oral doses of HS-10383

  3. Terminal Rate Constant [ Time Frame: up to 9 days ]
    To assess λz of single ascending oral doses of HS-10383

  4. Elimination Halflife [ Time Frame: up to 9 days ]
    To assess λz of single ascending oral doses of HS-10383

  5. 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

  6. Area Under the Concentration-time Curve0-∞ [ Time Frame: up to 9 days ]
    To assess AUC0-∞ of single ascending oral doses of HS-10383

  7. Clearance Rate [ Time Frame: up to 9 days ]
    To assess Clearance Rate of single ascending oral doses of HS-10383

  8. Apparent Volume of Distribution [ Time Frame: up to 9 days ]
    To assess Vd/F of single ascending oral doses of HS-10383

  9. Mean Retention Time [ Time Frame: up to 9 days ]
    To assess MRT of single ascending oral doses of HS-10383



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429723


Contacts
Layout table for location contacts
Contact: Wei Zhao, Doctor 15131190710 zhao4wei2@hotmail.com

Locations
Layout table for location information
China, Shandong
Shandong provincial qianfoshan hospital Recruiting
Jinan, Shandong, China, 250014
Contact: Wei Zhao, Doctor    15131190710    zhao4wei2@hotmail.com   
Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Wei Zhao, Doctor Qianfoshan Hospital
Layout table for additonal information
Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT05429723    
Other Study ID Numbers: HS-10383-101
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Hansoh Pharmaceutical Co., Ltd.:
RUCC, P2X3