Non-cystic Fibrosis Bronchiectasis、Chronic Sinusitis Without Nasal Polyps、Chronic Obstructive Pulmonary DiseasePhase 1NCT07696091
Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 Tablet
A Phase 1 study testing RSS0343 Tablet; Rifampicin Capsules and RSS0343 Tablet; Clarithromycin Tablets in people with Non-cystic Fibrosis Bronchiectasis、Chronic Sinusitis Without Nasal Polyps、Chronic Obstructive Pulmonary Disease, run by Reistone Biopharma Company Limited at 1 site in China.
Trial summary
This study is a single-center, single-sequence, self-controlled, open design, aiming to investigate the effects of rifampicin and clarithromycin on the pharmacokinetics of RSS0343 in humans. 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、Chronic Sinusitis Without Nasal Polyps、Chronic Obstructive Pulmonary Disease
- What is being tested?
- RSS0343 Tablet; Rifampicin Capsules and RSS0343 Tablet; Clarithromycin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Sep 2026
- Phase
- Phase 1
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
- The participants voluntarily signed the informed consent form, fully understanding the purpose and significance of this trial and willing to abide by the trial protocol.
- Age range: 18 - 55 years old (inclusive of both boundaries), open to both genders.
- Male weight ≥ 50 kg, female weight ≥ 45 kg. Body mass index (BMI) = weight (kg) / height² (m²). BMI is within the range of 19 to 28 kg/m² (including the boundary values).
- Male and female participants with reproductive capacity, as well as their partners, should have no plans for conception or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last administration of the drug, and should voluntarily adopt effective contraceptive measures. For female participants with reproductive capacity, the serum pregnancy test must be negative before the first administration of the drug, and they should not be in the lactation period.
Who cannot join
- Those who smoked more than 5 cigarettes per day in the previous 3 months (or used any nicotine-containing products), or those who planned to use any tobacco products during the trial period.
- Select individuals who have consumed alcohol frequently within the past 6 months (for women, the daily alcohol intake exceeds 15 g, and for men, it exceeds 25 g [5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, or approximately 17 mL of low-alcohol liquor]; and who cannot stop using any alcoholic products during the trial period); or those whose alcohol breath test was positive at baseline.
- Those with a history of drug abuse, drug use, drug dependence (during the consultation), or positive results from the baseline urine drug screening.
- Within one month before administration, having donated blood or experiencing blood loss of a total volume of ≥ 200 mL, or having donated blood or experienced blood loss of a total volume of ≥ 400 mL within the previous three months; or having received blood transfusion within the previous eight weeks; or having difficulty in venous blood collection, or being physically unable to withstand intensive blood collection.
- The researchers believe that participants who have other factors that make them unsuitable to participate in this trial.
- The results of physical examination, vital signs, laboratory tests (such as blood routine, urine routine, liver and kidney function, blood biochemistry, coagulation function, thyroid function, etc.), chest imaging, abdominal B-ultrasound and 12-lead electrocardiogram examination, when judged abnormal by the researchers, have clinical significance.
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- Those who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
- Suspected of being allergic to the studied drug or any component of the drug, or having a severe allergy to any medication, food, toxin or other exposure.
- Any history of severe clinical diseases or conditions that the researcher believes may affect the trial results, including but not limited to diseases of the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases; or conditions that the researcher believes may affect the research results or affect the absorption, distribution, metabolism and excretion of the drug or expose the participants to inappropriate risks.
- Exclude those who have undergone any surgery within the past 3 months, or those who have not fully recovered as determined by the researchers, or those who plan to undergo any surgery during the study period or within 1 month after the study concludes.
- Within the first 1 month before the baseline, or within 5 half-lives of the medication (whichever is longer), or during the study period, the use of other CYP3A inducers and inhibitors, any prescription drugs, over-the-counter drugs, including natural health supplements (with the exception of occasional use of paracetamol [up to 2g per day], ibuprofen, or regular use of vitamins) or Chinese herbal medicines.
- From 48 hours before the baseline until the end of the study, participants were required to refrain from consuming any beverages or foods containing methylxanthines, such as coffee, tea, cola, chocolate, etc.; from 7 days before the baseline until the end of the study, participants were required to refrain from consuming any beverages or foods containing grapefruit; those with special dietary requirements and unable to follow the unified diet.
- Those who received any live vaccine or attenuated live vaccine within the previous 1 month, or those who need to receive a live vaccine during the study period (including 30 days after the last administration of the study drug).
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
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405
Dawei Wang
Yan Ling
About this study
Official title: A Single-center, Single-sequence, Self-controlled Open Design Study , to Investigate the Effects of Rifampicin and Clarithromycin on the Pharmacokinetics of RSS0343.
This study is a single-center, single-sequence, self-controlled, open design, aiming to investigate the effects of rifampicin and clarithromycin on the pharmacokinetics of RSS0343 in humans.
- Being tested
- RSS0343 Tablet; Rifampicin Capsules, RSS0343 Tablet; Clarithromycin Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSS0343 Tablet; Rifampicin CapsulesDrug
RSS0343 Tablet; Rifampicin Capsules
RSS0343 Tablet; Clarithromycin TabletsDrug
RSS0343 Tablet; Clarithromycin Tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Rifampicin Capsules Group | Experimental | Not described Receives: Drug: RSS0343 Tablet; Rifampicin Capsules |
| Cohort B: Clarithromycin Tablets Group | Experimental | Not described Receives: Drug: RSS0343 Tablet; Clarithromycin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax; The maximum plasma concentration
Measured: Day1-Day38
AUC0-t; From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration
Measured: Day1-Day38
AUC0-inf；Area under the concentration curve from time 0 to extrapolated infinite time
Measured: Day1-Day38
Secondary outcomes (5)
Tmax; Time to maximum plasma concentration
Measured: Day1-Day38
t1/2; Terminal half-life
Measured: Day1-Day38
CL/F; Apparent clearance
Measured: Day1-Day38
Vz/F; Apparent volume of distribution
Measured: Day1-Day38
Safety ;Incidence and severity of adverse events
Measured: Day1-Day45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis Bronchiectasis、Chronic Sinusitis Without Nasal Polyps、Chronic Obstructive Pulmonary DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT07696091
- Sponsor's protocol ID
- RSS0343-103
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided