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

Cough Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092983
• Other study ID #: HS-10383-102
• Status: Recruiting
• Phase: Phase 1
• Start date: June 14, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cough

Intervention

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

Locations

Country	Name	City	State
China	Shandong provincial qianfoshan hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of treatment emergent adverse events	Safety and Tolerability Evaluation	up to 15 days
Primary	Number of participants experiencing AE with abnormal laboratory values	Safety and Tolerability Evaluation	up to 15 days
Primary	Number of participants experiencing AE with abnormal Electrocardiograph	Safety and Tolerability Evaluation	up to 15 days
Primary	Safety and Tolerability Evaluation	Number of participants experiencing AE with abnormal vital sign	up to 15 days
Secondary	Maximum plasma concentration (Cmax)	To assess Cmax of Multiple ascending oral doses of HS-10383	up to 192 hours after the last dose
Secondary	Area under the curve (AUC)	o assess AUC of Multiple ascending oral doses of HS-10383	up to 192 hours after the last dose
Secondary	Time of Maximum Concentration (Tmax)	To assess Tmax of Multiple ascending oral doses of HS-10383	up to 192 hours after the last dose