CoughPhase 1NCT06092983
A Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HS-10383
A Phase 1 study testing HS-10383 in people with Cough, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- HS-10383
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2023to 30 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong provincial qianfoshan hospital
Jinan, Shandong, 250014
Wei Zhao, Doctor, 15131190710, zhao4wei2@hotmail.com
About this study
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
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.
- Conditions
- Cough
- Being tested
- HS-10383, HS-10383 Placebo
- Keywords
- RUCC, P2X3
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10383Drug
Also called HS-10383 Tablets
HS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.
HS-10383 PlaceboDrug
Also called HS-10383 Placebo Tablets
HS-10383 Placebo administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization.
| Study group | Role | What they receive |
|---|---|---|
| HS-10383 (Multiple doses) | Experimental | Escalating doses of HS-10383 administered orally once daily for a week in healthy participants. Receives: 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. Receives: Drug: HS-10383 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of treatment emergent adverse events
Safety and Tolerability Evaluation
Measured: up to 15 days
Number of participants experiencing AE with abnormal laboratory values
Safety and Tolerability Evaluation
Measured: up to 15 days
Number of participants experiencing AE with abnormal Electrocardiograph
Safety and Tolerability Evaluation
Measured: up to 15 days
Safety and Tolerability Evaluation
Number of participants experiencing AE with abnormal vital sign
Measured: up to 15 days
Secondary outcomes (3)
Maximum plasma concentration (Cmax)
To assess Cmax of Multiple ascending oral doses of HS-10383
Measured: up to 192 hours after the last dose
Area under the curve (AUC)
- assess AUC of Multiple ascending oral doses of HS-10383
Measured: up to 192 hours after the last dose
Time of Maximum Concentration (Tmax)
To assess Tmax of Multiple ascending oral doses of HS-10383
Measured: up to 192 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start14 Jun 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092983
- Sponsor's protocol ID
- HS-10383-102
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06092983
- Acronym / sponsor ID
- HS-10383-102
- Conditions
- Cough
- Keywords
- RUCC, P2X3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10383 (Multiple doses) | Experimental | Drug: HS-10383Escalating doses of HS-10383 administered orally once daily for a week in healthy participants. |
| HS-10383 Placebo (Multiple doses) | Placebo comparator | Drug: HS-10383 PlaceboEscalating doses of HS-10383 Placebo administered orally daily for a week in healthy participants. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10383Also: HS-10383 TabletsHS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization. | Drug | HS-10383 (Multiple doses) |
| HS-10383 PlaceboAlso: HS-10383 Placebo TabletsHS-10383 Placebo administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization. | Drug | HS-10383 Placebo (Multiple doses) |
Primary outcome
Number and severity of treatment emergent adverse events
Time frame: up to 15 days
Safety and Tolerability Evaluation
Number of participants experiencing AE with abnormal laboratory values
Time frame: up to 15 days
Safety and Tolerability Evaluation
Number of participants experiencing AE with abnormal Electrocardiograph
Time frame: up to 15 days
Safety and Tolerability Evaluation
Safety and Tolerability Evaluation
Time frame: up to 15 days
Number of participants experiencing AE with abnormal vital sign
3 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: up to 192 hours after the last dose
Area under the curve (AUC)
Time frame: up to 192 hours after the last dose
Time of Maximum Concentration (Tmax)
Time frame: up to 192 hours after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10383 in people with Cough, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of treatment emergent adverse events (time frame: up to 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.