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Status unknownNCT06092983Updated Oct 23, 2023

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

A Phase 1 interventional study of HS-10383 and HS-10383 Placebo in Cough, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. (part of Hansoh Pharmaceutical Group Company Limited) · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cough

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Keywords

  • RUCC, P2X3
03

In context

Cough

355 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's planned enrollment of 48 is below the median of 71 across 270 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 135 studies on the registry; 71 are open to participants now.

Browse Jiangsu Hansoh Pharmaceutical Co., Ltd. studies →All Hansoh Pharmaceutical Group Company Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    HS-10383 (Multiple doses)

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

    Drug: HS-10383

  • 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

Interventions

  • DrugHS-10383

    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

  • DrugHS-10383 Placebo

    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

06

What researchers measure

Primary outcomes

  1. Number and severity of treatment emergent adverse events

    Safety and Tolerability Evaluation

    Time frame: up to 15 days

  2. Number of participants experiencing AE with abnormal laboratory values

    Safety and Tolerability Evaluation

    Time frame: up to 15 days

  3. Number of participants experiencing AE with abnormal Electrocardiograph

    Safety and Tolerability Evaluation

    Time frame: up to 15 days

  4. Safety and Tolerability Evaluation

    Number of participants experiencing AE with abnormal vital sign

    Time frame: up to 15 days

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    To assess Cmax of Multiple ascending oral doses of HS-10383

    Time frame: up to 192 hours after the last dose

  2. Area under the curve (AUC)

    o assess AUC of Multiple ascending oral doses of HS-10383

    Time frame: up to 192 hours after the last dose

  3. Time of Maximum Concentration (Tmax)

    To assess Tmax of Multiple ascending oral doses of HS-10383

    Time frame: up to 192 hours after the last dose

07

Study locations

1 of 1 sites recruiting
  • Shandong provincial qianfoshan hospital
    Jinan, Shandong 250014, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06092983
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Jun 14, 2023
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Oct 23, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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