Clinical trial NCT06092983: A Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HS-10383
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cough
Keywords: RUCC, P2X3
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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);

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;

Primary outcomes:
measure: Number and severity of treatment emergent adverse events
timeFrame: up to 15 days
measure: Number of participants experiencing AE with abnormal laboratory values
timeFrame: up to 15 days
measure: Number of participants experiencing AE with abnormal Electrocardiograph
timeFrame: up to 15 days
measure: Safety and Tolerability Evaluation
timeFrame: up to 15 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 192 hours after the last dose
measure: Area under the curve (AUC)
timeFrame: up to 192 hours after the last dose
measure: Time of Maximum Concentration (Tmax)
timeFrame: up to 192 hours after the last dose
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong provincial qianfoshan hospital
state: Shandong
Study officials:
References: