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

Phase 1

Recruiting

• Conditions: Cough
• Interventions: Drug: HS-10383 Placebo; Drug: HS-10383

• Registration Number: NCT06092983
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-30
• Study Start: 2023-06-14
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HS-10383 Placebo (Multiple doses)	HS-10383 Placebo	Escalating doses of HS-10383 Placebo administered orally daily for a week in healthy participants.
HS-10383 (Multiple doses)	HS-10383	Escalating doses of HS-10383 administered orally once daily for a week in healthy participants.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Evaluation	up to 15 days	Number of participants experiencing AE with abnormal vital sign
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

Secondary Outcome Measures

Name	Time	Method
Area under the curve (AUC)	up to 192 hours after the last dose	o assess AUC 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
Time of Maximum Concentration (Tmax)	up to 192 hours after the last dose	To assess Tmax of Multiple ascending oral doses of HS-10383

Trial Locations

Locations (1)

Shandong provincial qianfoshan hospital; 🇨🇳 Jinan, Shandong, China