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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cough
• Intervention / Treatment: Drug: HS-10383; Drug: HS-10383 Placebo

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • ShanDong Provincial QianFoShan Hospital
      • Contact: Wei Zhao, Doctor; Phone Number: 15131190710; Email: zhao4wei2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10383 (Multiple doses); Escalating doses of HS-10383 administered orally once daily for a week in healthy participants.	Drug: HS-10383; HS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.; Other Names: HS-10383 Tablets
Placebo Comparator: HS-10383 Placebo (Multiple doses); Escalating doses of HS-10383 Placebo administered orally daily for a week in healthy participants.	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.; Other Names: HS-10383 Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of treatment emergent adverse events	Safety and Tolerability Evaluation	up to 15 days
Number of participants experiencing AE with abnormal laboratory values	Safety and Tolerability Evaluation	up to 15 days
Number of participants experiencing AE with abnormal Electrocardiograph	Safety and Tolerability Evaluation	up to 15 days
Safety and Tolerability Evaluation	Number of participants experiencing AE with abnormal vital sign	up to 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	To assess Cmax of Multiple ascending oral doses of HS-10383	up to 192 hours after the last dose
Area under the curve (AUC)	o assess AUC of Multiple ascending oral doses of HS-10383	up to 192 hours after the last dose
Time of Maximum Concentration (Tmax)	To assess Tmax of Multiple ascending oral doses of HS-10383	up to 192 hours after the last dose

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: RUCC, P2X3
• Other Study ID Numbers: HS-10383-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No