Non-cystic Fibrosis BronchiectasisPhase 1NCT07289464
A Clinical Study of RSS0343 in Healthy Subjects
A Phase 1 study testing RSS0343 Tablets in people with Non-cystic Fibrosis Bronchiectasis, run by Reistone Biopharma Company Limited at 1 site in China.
Trial summary
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- RSS0343 Tablets
- 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
- 8 Jan 2026to 10 Aug 2026
- 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
- Subjects who provided written informed consent after being fully informed of the trial's purpose, significance, and protocol requirements.
- Healthy individuals aged 18 to 55 years, inclusive. Males and females
- Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height 2 (m²). BMI between 19 and 28 kg/m², inclusive.
- Fertile male and female subjects and their partners must agree to use highly effective contraception as stipulated in the protocol, from screening until 6 months (for females) or 3 months (for males) after the last dose. Additionally, fertile female subjects must have a negative serum pregnancy test at screening and prior to the first dose (baseline) and must not be lactating.
Who cannot join
- Subjects who smoked more than 5 cigarettes (or equivalent nicotine products) daily within 3 months prior to screening or intended to use tobacco products during the trial.
- Subjects with frequent alcohol consumption (>15 g/day for females or >25 g/day for males [5g of alcohol is equivalent to 150 mL of beer, 50 mL of wine or approximately 17 mL of low-alcohol liquor], on more than 2 occasions per week) within 6 months prior to screening, or were unable to abstain during the trial, or who tested positive on the alcohol breath test at baseline.
- Subjects with a history of, or current, drug abuse, or drug dependence (during consultation), or with a positive urine drug screening result.
- Subjects who had donated blood or experienced a total blood loss of ≥200 mL within 1 month, or ≥400 mL within 3 months prior to dosing, or who had received a blood transfusion within 8 weeks prior to dosing.
- Subjects with dysphagia; or a history of needle or blood phobia, poor venous access, or inability to tolerate venipuncture.
- Subjects deemed by the investigators to be unsuitable for the trial for any other reason.
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- Subjects with any clinically significant abnormalities, as determined by the investigator, in physical examination, vital signs, laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation), chest imaging, abdominal ultrasonography, or electrocardiogram.
- Subjects who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
- Subjects with a known or suspected allergy to the investigational drug or its excipients, or a history of severe allergic reactions (e.g., to drugs, food, toxins).
- Subjects with any active autoimmune disease or immunodeficiency at screening.
- Subjects with any history of severe clinical disease, or any condition that, in the investigator's judgment, could compromise trial outcomes, affect drug absorption, distribution, metabolism, or excretion (pharmacokinetics), or pose an undue risk to the subject. This includes, but is not limited to, significant disorders of the circulatory, endocrine, nervous, digestive, urinary, hematological, immune, psychiatric, or metabolic systems.
- Subjects who had undergone any surgery within 3 months prior to screening, had not fully recovered as determined by the investigator, or planned to undergo surgery during the trial or within 1 month after its completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RSS0343 Following Multiple Oral Doses in Healthy Subjects, as Well as Its Effects on the QT/QTc Interval
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- RSS0343 Tablets, RSS0343 Tablets Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSS0343 TabletsDrug
RSS0343 tablets, oral.
RSS0343 Tablets PlaceboDrug
RSS0343 tablets placebo, oral.
| Study group | Role | What they receive |
|---|---|---|
| RSS0343 Tablets Group | Experimental | Not described Receives: Drug: RSS0343 Tablets |
| RSS0343 Tablets Placebo Group | Placebo comparator | Not described Receives: Drug: RSS0343 Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of any adverse events (AEs).
Safety and tolerability.
Measured: Evaluation was performed up to Day 28.
Secondary outcomes (14)
Maximum observed plasma concentration of RSS0343 at Day 1 (Cmax).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Maximum observed plasma concentration of RSS0343 at steady state (Cmax,ss).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Time to Cmax (Tmax).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Time to Cmax,ss (Tmax,ss).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Area under the concentration-time curve during a dosing interval (AUC0-tau).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Area under the concentration-time curve from 0 to the last measurable time point after RSS0343 administration (AUC0-t).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Area under the concentration-time curve from time 0 to infinity after RSS0343 administration (AUC0-inf).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Terminal elimination half-life of RSS0343 (t1/2).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Apparent clearance of RSS0343 during multiple dosing with a dosing interval of time tau (CLss/F).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Apparent volume of distribution during terminal elimination phase of RSS0343 at steady state (Vss/F).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Cumulative amount of drug excreted in urine (Ae,urine).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Cumulative percentage of dose recovered in urine (Fe,urine).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Renal clearance of RSS0343 (CLr).
Pharmacokinetics (PK) indicator.
Measured: Evaluation was performed up to Day 28.
Changes in the QTc interval corrected by the Fridericia method relative to baseline (ΔQTcF) (where applicable).
To evaluate the effects of RSS0343 on the QT/QTc interval in healthy subjects.
Measured: Evaluation was performed up to Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start8 Jan 2026
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289464
- Sponsor's protocol ID
- RSS0343-102
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2025
- Last updated
- 17 Aug 2026
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RSS0343 Following Multiple Oral Doses in Healthy Subjects, as Well as Its Effects on the QT/QTc Interval
- ClinicalTrials.gov ID
- NCT07289464
- Acronym / sponsor ID
- RSS0343-102
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 17 Dec 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.
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSS0343 Tablets Group | Experimental | Drug: RSS0343 Tablets |
| RSS0343 Tablets Placebo Group | Placebo comparator | Drug: RSS0343 Tablets Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who provided written informed consent after being fully informed of the trial's purpose, significance, and protocol requirements.
- Healthy individuals aged 18 to 55 years, inclusive. Males and females
- Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height 2 (m²). BMI between 19 and 28 kg/m², inclusive.
- Fertile male and female subjects and their partners must agree to use highly effective contraception as stipulated in the protocol, from screening until 6 months (for females) or 3 months (for males) after the last dose. Additionally, fertile female subjects must have a negative serum pregnancy test at screening and prior to the first dose (baseline) and must not be lactating.
Key exclusion criteria (12 listed)
- Subjects who smoked more than 5 cigarettes (or equivalent nicotine products) daily within 3 months prior to screening or intended to use tobacco products during the trial.
- Subjects with frequent alcohol consumption (>15 g/day for females or >25 g/day for males [5g of alcohol is equivalent to 150 mL of beer, 50 mL of wine or approximately 17 mL of low-alcohol liquor], on more than 2 occasions per week) within 6 months prior to screening, or were unable to abstain during the trial, or who tested positive on the alcohol breath test at baseline.
- Subjects with a history of, or current, drug abuse, or drug dependence (during consultation), or with a positive urine drug screening result.
- Subjects who had donated blood or experienced a total blood loss of ≥200 mL within 1 month, or ≥400 mL within 3 months prior to dosing, or who had received a blood transfusion within 8 weeks prior to dosing.
- Subjects with dysphagia; or a history of needle or blood phobia, poor venous access, or inability to tolerate venipuncture.
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 TabletsRSS0343 tablets, oral. | Drug | RSS0343 Tablets Group |
| RSS0343 Tablets PlaceboRSS0343 tablets placebo, oral. | Drug | RSS0343 Tablets Placebo Group |
Primary outcome
Incidence and severity of any adverse events (AEs).
Time frame: Evaluation was performed up to Day 28.
Safety and tolerability.
14 secondary outcomes
Maximum observed plasma concentration of RSS0343 at Day 1 (Cmax).
Time frame: Evaluation was performed up to Day 28.
Maximum observed plasma concentration of RSS0343 at steady state (Cmax,ss).
Time frame: Evaluation was performed up to Day 28.
Time to Cmax (Tmax).
Time frame: Evaluation was performed up to Day 28.
Time to Cmax,ss (Tmax,ss).
Time frame: Evaluation was performed up to Day 28.
Area under the concentration-time curve during a dosing interval (AUC0-tau).
Time frame: Evaluation was performed up to Day 28.
Area under the concentration-time curve from 0 to the last measurable time point after RSS0343 administration (AUC0-t).
Time frame: Evaluation was performed up to Day 28.
Area under the concentration-time curve from time 0 to infinity after RSS0343 administration (AUC0-inf).
Time frame: Evaluation was performed up to Day 28.
Terminal elimination half-life of RSS0343 (t1/2).
Time frame: Evaluation was performed up to Day 28.
Apparent clearance of RSS0343 during multiple dosing with a dosing interval of time tau (CLss/F).
Time frame: Evaluation was performed up to Day 28.
Apparent volume of distribution during terminal elimination phase of RSS0343 at steady state (Vss/F).
Time frame: Evaluation was performed up to Day 28.
Cumulative amount of drug excreted in urine (Ae,urine).
Time frame: Evaluation was performed up to Day 28.
Cumulative percentage of dose recovered in urine (Fe,urine).
Time frame: Evaluation was performed up to Day 28.
Renal clearance of RSS0343 (CLr).
Time frame: Evaluation was performed up to Day 28.
Changes in the QTc interval corrected by the Fridericia method relative to baseline (ΔQTcF) (where applicable).
Time frame: Evaluation was performed up to Day 28.
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 17 Aug 2026.
- 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 testing RSS0343 Tablets in people with Non-cystic Fibrosis Bronchiectasis, run by Reistone Biopharma Company Limited 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 12 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 17 Aug 2026. 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?
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?
Incidence and severity of any adverse events (AEs). (time frame: Evaluation was performed up to Day 28.). 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 17 Aug 2026.