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A Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HS-10383

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06092983
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
6.5
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

HS-10383 is a selective P2X3 receptor antagonist being developed for the treatment of refractory/unexplained chronic cough. This Phase 1b study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 administered orally to healthy subjects.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo Controlled, Phase Ib Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple-Dose Escalation HS-10383 in Healthy Adult Subjects
Actual Study Start Date :
Jun 14, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HS-10383 (Multiple doses)

Escalating doses of HS-10383 administered orally once daily for a week in healthy participants.

Drug: HS-10383
HS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.
Other Names:
  • HS-10383 Tablets

    		•
    Placebo Comparator: HS-10383 Placebo (Multiple doses)

    Escalating doses of HS-10383 Placebo administered orally daily for a week in healthy participants.

    Drug: HS-10383 Placebo
    HS-10383 Placebo administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.
    Other Names:
  • HS-10383 Placebo Tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number and severity of treatment emergent adverse events [up to 15 days]

      Safety and Tolerability Evaluation

    2. Number of participants experiencing AE with abnormal laboratory values [up to 15 days]

      Safety and Tolerability Evaluation

    3. Number of participants experiencing AE with abnormal Electrocardiograph [up to 15 days]

      Safety and Tolerability Evaluation

    4. Safety and Tolerability Evaluation [up to 15 days]

      Number of participants experiencing AE with abnormal vital sign

    Secondary Outcome Measures

    1. Maximum plasma concentration (Cmax) [up to 192 hours after the last dose]

      To assess Cmax of Multiple ascending oral doses of HS-10383

    2. Area under the curve (AUC) [up to 192 hours after the last dose]

      o assess AUC of Multiple ascending oral doses of HS-10383

    3. Time of Maximum Concentration (Tmax) [up to 192 hours after the last dose]

      To assess Tmax of Multiple ascending oral doses of HS-10383

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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);

    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandong provincial qianfoshan hospital Jinan Shandong China 250014

    Sponsors and Collaborators

    • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangsu Hansoh Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT06092983
    Other Study ID Numbers:
    • HS-10383-102
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    May 1, 2023
    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

    Study Results

    No Results Posted as of Oct 23, 2023