A Clinical Study of RSS0343 in Healthy Subjects

Официальное название

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

Обзор

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.

Вмешательства

• Препарат RSS0343 Tablets
  RSS0343 tablets, oral.
• Препарат RSS0343 Tablets Placebo
  RSS0343 tablets placebo, oral.

Первичные конечные точки

• Incidence and severity of any adverse events (AEs). [Срок оценки: Evaluation was performed up to Day 28.]

Вторичные конечные точки (12)

• Maximum observed plasma concentration of RSS0343 at Day 1 (Cmax). [Срок оценки: Evaluation was performed up to Day 28.]
• Maximum observed plasma concentration of RSS0343 at steady state (Cmax,ss). [Срок оценки: Evaluation was performed up to Day 28.]
• Time to Cmax (Tmax). [Срок оценки: Evaluation was performed up to Day 28.]
• Time to Cmax,ss (Tmax,ss). [Срок оценки: Evaluation was performed up to Day 28.]
• Area under the concentration-time curve during a dosing interval (AUC0-tau). [Срок оценки: 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). [Срок оценки: Evaluation was performed up to Day 28.]
• Area under the concentration-time curve from time 0 to infinity after RSS0343 administration (AUC0-inf). [Срок оценки: Evaluation was performed up to Day 28.]
• Terminal elimination half-life of RSS0343 (t1/2). [Срок оценки: Evaluation was performed up to Day 28.]
• Apparent clearance of RSS0343 during multiple dosing with a dosing interval of time tau (CLss/F). [Срок оценки: Evaluation was performed up to Day 28.]
• Apparent volume of distribution during terminal elimination phase of RSS0343 at steady state (Vss/F). [Срок оценки: Evaluation was performed up to Day 28.]
• Cumulative amount of drug excreted in urine (Ae,urine). [Срок оценки: Evaluation was performed up to Day 28.]
• Cumulative percentage of dose recovered in urine (Fe,urine). [Срок оценки: Evaluation was performed up to Day 28.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongnan Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT07289464 · RSS0343-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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