NCT07696091Not yet recruitingPhase 1
A Single-center, Single-sequence, Self-controlled Open Design Study , to Investigate the Effects of Rifampicin and Clarithromycin on the Pharmacokinetics of RSS0343.
Reistone Biopharma Company Limited1 site in 1 country40 target enrollmentStarted: July 1, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cmax; The maximum plasma concentration
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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).
Outcomes
Primary Outcomes
Cmax; The maximum plasma concentration
Time Frame: Day1-Day38
AUC0-t; From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration
Time Frame: Day1-Day38
AUC0-inf；Area under the concentration curve from time 0 to extrapolated infinite time
Time Frame: Day1-Day38
Secondary Outcomes
- Tmax; Time to maximum plasma concentration(Day1-Day38)
- t1/2; Terminal half-life(Day1-Day38)
- CL/F; Apparent clearance(Day1-Day38)
- Vz/F; Apparent volume of distribution(Day1-Day38)
- Safety ;Incidence and severity of adverse events(Day1-Day45)
Investigators
Study Sites (1)
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