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

NCT ID: NCT06092983

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2023-12-30

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.

Conditions

Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HS-10383 (Multiple doses)

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

Group Type: EXPERIMENTAL

HS-10383

Intervention Type: DRUG

HS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.

HS-10383 Placebo (Multiple doses)

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

Group Type: PLACEBO_COMPARATOR

HS-10383 Placebo

Intervention Type: DRUG

HS-10383 Placebo administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.

Interventions

HS-10383

HS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

HS-10383 Tablets; HS-10383 Placebo Tablets

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong provincial qianfoshan hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wei Zhao, Doctor

Role: primary

zhao4wei2@hotmail.com

15131190710

Other Identifiers

HS-10383-102

Identifier Type: -

Identifier Source: org_study_id