Adolescent AsthmaPhase 2NCT06775340
Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
A Phase 2 study testing RSS0343 Tabella in people with Adolescent Asthma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adolescent Asthma
- What is being tested?
- RSS0343 Tabella
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old (including boundary values), male and female.
- Female subjects weigh ≥45 kg and male subjects weigh ≥50 kg.
- HRCT shows bronchiectasis affecting one or more lobes of the lung and is confirmed by the clinician as NCFB.
- The expected survival is greater than 12 months.
- Informed consent was signed before the trial.
- Potentially fertile subjects voluntarily take appropriate contraceptive measures.
Who cannot join
- Patients with pulmonary hypertension or chronic obstructive pulmonary disease (COPD) or asthma as determined by the investigators were the primary diagnosis were screened.
- An active, symptomatic infection caused by respiratory viruses, including COVID-19, influenza viruses, etc.
- Have psoriasis or lichen planus.
- Have Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis.
- Have chlorine acne, large common warts, or keratodermatitis.
- Has diabetic foot.
Show all 22Show fewer
- Have periodontal disease, oral infection, or loose teeth.
- History of malignant tumor within 5 years prior to screening.
- Screening subjects with a history of liver disease or currently receiving treatment for liver disease, including but not limited to acute or chronic hepatitis, cirrhosis, or liver failure.
- Researchers consider any other unstable clinical disease.
- Oral or inhaled antibiotics were received 4 weeks prior to first administration.
- Immunosuppressants were administered 4 weeks before the first dose.
- Received drugs within 4 weeks prior to screening that may cause hyperkeratosis of the skin.
- Received live attenuated vaccine within 30 days prior to initial administration.
- Participated in clinical trials of any medical device within 3 months prior to screening.
- Active hepatitis B virus infection, active hepatitis C virus infection, or known HIV infection or known syphilis infection.
- Drug abusers.
- Current smoker or former smoker for less than 3 months.
- Suspected allergy to the investigational product or any component of the investigational product, or severe allergy to any drug, food, toxin or other exposure.
- Pregnant or lactating women.
- The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.
- The researchers determined that there were other circumstances that were not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510140
Weijie Guan
About this study
Official title: Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis
- Conditions
- Adolescent Asthma
- Being tested
- RSS0343 Tabella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSS0343 TabellaDrug
RSS0343 tablets, oral;
| Study group | Role | What they receive |
|---|---|---|
| RSS0343 Tabella | Experimental | Not described Receives: Drug: RSS0343 Tabella |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of occurrences of AEs
Measured: Day 1 to Day56
the frequency of occurrence of AEs
Measured: Day 1 to Day56
Secondary outcomes (4)
RSS0343 amount of tablets of their metabolites in the blood
Measured: Day7, Day14, Day21, Day 28
Changes in the concentrations of active neutrophil elastase (NE) in sputum
Measured: Day7, Day14, Day21, Day 28, Day 56
Changes in the concentrations of cathepsin G (CatG) in sputum
Measured: Day7, Day14, Day21, Day 28, Day 56
Changes in the concentrations of enzyme protease 3 (PR3) in sputum
Measured: Day7, Day14, Day21, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start22 Jan 2025
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent AsthmaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775340
- Sponsor's protocol ID
- RSS0343-201
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT06775340
- Acronym / sponsor ID
- RSS0343-201
- Conditions
- Adolescent Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jan 2025 (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.
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSS0343 Tabella | Experimental | Drug: RSS0343 Tabella |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years old (including boundary values), male and female.
- Female subjects weigh ≥45 kg and male subjects weigh ≥50 kg.
- HRCT shows bronchiectasis affecting one or more lobes of the lung and is confirmed by the clinician as NCFB.
- The expected survival is greater than 12 months.
- Informed consent was signed before the trial.
Key exclusion criteria (22 listed)
- Patients with pulmonary hypertension or chronic obstructive pulmonary disease (COPD) or asthma as determined by the investigators were the primary diagnosis were screened.
- An active, symptomatic infection caused by respiratory viruses, including COVID-19, influenza viruses, etc.
- Have psoriasis or lichen planus.
- Have Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis.
- Have chlorine acne, large common warts, or keratodermatitis.
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 |
|---|---|---|
| RSS0343 TabellaRSS0343 tablets, oral; | Drug | RSS0343 Tabella |
Primary outcome
The number of occurrences of AEs
Time frame: Day 1 to Day56
the frequency of occurrence of AEs
Time frame: Day 1 to Day56
4 secondary outcomes
RSS0343 amount of tablets of their metabolites in the blood
Time frame: Day7, Day14, Day21, Day 28
Changes in the concentrations of active neutrophil elastase (NE) in sputum
Time frame: Day7, Day14, Day21, Day 28, Day 56
Changes in the concentrations of cathepsin G (CatG) in sputum
Time frame: Day7, Day14, Day21, Day 28, Day 56
Changes in the concentrations of enzyme protease 3 (PR3) in sputum
Time frame: Day7, Day14, Day21, Day 28, Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RSS0343 Tabella in people with Adolescent Asthma, run by Jiangsu HengRui Medicine 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 6 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zi Lin (+0518-81220121, zi.lin.zl30@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of occurrences of AEs (time frame: Day 1 to Day56). The study lists 2 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 13 May 2025.