Cough
Conditions
Keywords
RUCC, P2X3
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.
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.
Interventions
DRUGHS-10383
HS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.
DRUGHS-10383 Placebo
HS-10383 Placebo administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of treatment emergent adverse events | up to 15 days | Safety and Tolerability Evaluation |
| Number of participants experiencing AE with abnormal laboratory values | up to 15 days | Safety and Tolerability Evaluation |
| Number of participants experiencing AE with abnormal Electrocardiograph | up to 15 days | Safety and Tolerability Evaluation |
| Safety and Tolerability Evaluation | up to 15 days | Number of participants experiencing AE with abnormal vital sign |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) | up to 192 hours after the last dose | o assess AUC of Multiple ascending oral doses of HS-10383 |
| Time of Maximum Concentration (Tmax) | up to 192 hours after the last dose | To assess Tmax of Multiple ascending oral doses of HS-10383 |
| Maximum plasma concentration (Cmax) | up to 192 hours after the last dose | To assess Cmax of Multiple ascending oral doses of HS-10383 |
Countries
China
Outcome results
None listed