Chronic CoughPhase 1NCT05274516
A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration
A Phase 1 study of Chronic Cough, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cough
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2022to 25 Oct 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to provide a written informed consent.
- Age 18 to 55 years (inclusive).
- Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
- Medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound and chest radiography) normal or abnormal with no clinical significance.
Who cannot join
- Any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results.
- Subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; Subjects who plan to undergo surgery during the trial period and within two weeks after the trial.
- Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
- Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
- Subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening.
- Subjects who had a history of smoking in the previous 3 months (average daily smoking > 5 cigarettes), or who could not stop using any tobacco products during the test period.
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- Subjects who consumed more than 15g of alcohol per day on average (15g of alcohol is equivalent to 450 mL beer, 150 mL wine or about 50mL low-alcohol white wine) or tested positive for alcohol during the 3 months prior to screening, or who could not abstain from alcohol during the test period.
- Subjects with a history of drug abuse, drug dependence or positive drug screening.
- Determined by the investigator to be unfit to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The second hospital of Anhui Medical University
Hefei, Anhui, 510120
About this study
Official title: Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of HRS-2261, the Effects of Food on the Pharmacokinetics of HRS-2261, and the Effects of HRS-2261 on CYP3A4 Metabolic Enzymes in Healthy Subjects After Single and Multiple Oral Administration
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.
- Conditions
- Chronic Cough
- Being tested
- HRS-2261 tablet、placebo
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2261 tablet、placeboDrug
HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.
HRS-2261 tablet、placeboDrug
HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses, 6 dose levels | Experimental | HRS-2261 oral tablet Matching placebo to HRS-2261 Receives: Drug: HRS-2261 tablet、placebo |
| Multiple Ascending Doses, 3 dose levels | Experimental | HRS-2261 oral tablet Matching placebo to HRS-2261 Receives: Drug: HRS-2261 tablet、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 (TEAEs)
Number and severity of TEAEs collected from dosing until follow up 7 days after last dose
Measured: up to 7 days after the last dose
Secondary outcomes (4)
Area under the curve (AUC)
To assess AUC of single and multiple ascending oral doses of HRS-2261
Measured: up to 7 days after the last dose
Maximum plasma concentration (Cmax)
To assess Cmax of single and multiple ascending oral doses of HRS-2261
Measured: up to 7 days after the last dose
Area under the curve (AUC) under fed conditions
To assess AUC of a single oral dose of HRS-2261 under fed conditions
Measured: up to 7 days after the last dose
Maximum plasma concentration (Cmax) under fed conditions
To assess Cmax of a single oral dose of HRS-2261 under fed conditions
Measured: up to 7 days 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 posted10 Mar 2022
- Study start28 Mar 2022
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- Parallel groups
- Model description
- HRS-2261 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274516
- Sponsor's protocol ID
- HRS-2261-101
- Status last verified
- Oct 2022
- First submitted
- 2 Mar 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fan Y, Zhang X, Zhang Q, Zheng L, Zhou R, Sun C, Wang X, Song K, He Z, Wang H, Zhang Q, Hu W. Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clin Pharmacokinet. 2024 Mar;63(3):293-302. doi: 10.1007/s40262-023-01330-7. Epub 2024 Jan 10.
PubMed 38198010
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of HRS-2261, the Effects of Food on the Pharmacokinetics of HRS-2261, and the Effects of HRS-2261 on CYP3A4 Metabolic Enzymes in Healthy Subjects After Single and Multiple Oral Administration
- ClinicalTrials.gov ID
- NCT05274516
- Acronym / sponsor ID
- HRS-2261-101
- Conditions
- Chronic Cough
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 10 Mar 2022 (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 is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HRS-2261 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses, 6 dose levels | Experimental | Drug: HRS-2261 tablet、placeboHRS-2261 oral tablet Matching placebo to HRS-2261 |
| Multiple Ascending Doses, 3 dose levels | Experimental | Drug: HRS-2261 tablet、placeboHRS-2261 oral tablet Matching placebo to HRS-2261 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able and willing to provide a written informed consent.
- Age 18 to 55 years (inclusive).
- Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
- Medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound and chest radiography) normal or abnormal with no clinical significance.
Key exclusion criteria (9 listed)
- Any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results.
- Subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; Subjects who plan to undergo surgery during the trial period and within two weeks after the trial.
- Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
- Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
- Subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening.
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 |
|---|---|---|
| HRS-2261 tablet、placeboHRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose. | Drug | Single Ascending Doses, 6 dose levels |
| HRS-2261 tablet、placeboHRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID. | Drug | Multiple Ascending Doses, 3 dose levels |
Primary outcome
Number and severity of treatment emergent adverse events (TEAEs)
Time frame: up to 7 days after the last dose
Number and severity of TEAEs collected from dosing until follow up 7 days after last dose
4 secondary outcomes
Area under the curve (AUC)
Time frame: up to 7 days after the last dose
Maximum plasma concentration (Cmax)
Time frame: up to 7 days after the last dose
Area under the curve (AUC) under fed conditions
Time frame: up to 7 days after the last dose
Maximum plasma concentration (Cmax) under fed conditions
Time frame: up to 7 days after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 38198010Fan Y, Zhang X, Zhang Q, Zheng L, Zhou R, Sun C, Wang X, Song K, He Z, Wang H, Zhang Q, Hu W. Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clin Pharmacokinet. 2024 Mar;63(3):293-302. doi: 10.1007/s40262-023-01330-7. Epub 2024 Jan 10.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Chronic Cough, run by Guangdong Hengrui 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 5 Apr 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of treatment emergent adverse events (TEAEs) (time frame: up to 7 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274516, which also lists 1 linked publication.
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 5 Apr 2023.