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

NCT06092983 | Unknown Phase 1

• 1 other identifier: HS-10383-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

RUCC, P2X3

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Maximum plasma concentration (Cmax)

  up to 192 hours after the last dose

• Area under the curve (AUC)

  up to 192 hours after the last dose

• Time of Maximum Concentration (Tmax)

  up to 192 hours after the last dose

Study Arms (2)

HS-10383 (Multiple doses)

EXPERIMENTAL

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

Drug: HS-10383

HS-10383 Placebo (Multiple doses)

PLACEBO COMPARATOR

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

Drug: HS-10383 Placebo

Interventions

HS-10383 DRUG

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

Also known as: HS-10383 Tablets

HS-10383 (Multiple doses)

HS-10383 Placebo DRUG

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

Also known as: HS-10383 Placebo Tablets

HS-10383 Placebo (Multiple doses)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants aged from 18 to 45 years
• Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily sign the informed consent;
• 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);

You may not qualify if:

• 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;
• Any known presence or history of hypogeusia, abnormal taste or dysgeusia;
• Any known presence or history of severe allergies, or known to be allergic to the components of the test drug;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong provincial qianfoshan hospital

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: October 23, 2023
• Study Start: June 14, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-05

Locations

CN (1)