Status:
UNKNOWN
A Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HS-10383
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Cough
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 cente...
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 pharmacoki...
Eligibility Criteria
Inclusion
- Healthy participants aged from 18 to 45 years
- Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily sign the informed consent;
- 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
- 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;
- Any known presence or history of hypogeusia, abnormal taste or dysgeusia;
- Any known presence or history of severe allergies, or known to be allergic to the components of the test drug;
- 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;
- 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;
- 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;
Key Trial Info
Start Date :
June 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06092983
Start Date
June 14 2023
End Date
December 30 2023
Last Update
October 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shandong provincial qianfoshan hospital
Jinan, Shandong, China, 250014