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Набор скоро начнётся NCT07302035

A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women

Фаза I С лечением Bacterial Vaginosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: GenSci142, Placebo GenSci142.
Кому может быть актуально
Состояния в реестре: Bacterial Vaginosis. Базовые параметры: 18 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Phase Ia Single-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Trial of GenSci142 Administered in Single Ascending Doses in Healthy Chinese Women

Обзор

This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.

Подробное описание

This is a Phase 1a trial including single ascending dose levels and will assess the safety and tolerability of GenSci142 and describe the incidence of adverse events (AEs) for participants randomized at a ratio of 4:1 to GenSci142 or placebo within each cohort. Participants will receive one single dose of study treatment.

Вмешательства

  • Препарат GenSci142
    Vaginal insert
  • Препарат Placebo GenSci142
    Vaginal insert

Первичные конечные точки

  • Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose [Срок оценки: from first dose of study treatment up to 15 days post-dose]
Вторичные конечные точки (9)
  • Serum concentration of GenSci142 (ng/mL) [Срок оценки: Day1-Day3]
  • Maximum serum concentration (Cmax, ng/mL) [Срок оценки: Day1-Day3]
  • Time to maximum serum concentration (Tmax, h) [Срок оценки: Day1-Day3]
  • Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL) [Срок оценки: Day1-Day3]
  • Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL) [Срок оценки: Day1-Day3]
  • Terminal half-life (t1/2, h) [Срок оценки: Day1-Day3]
  • Apparent clearance (CL/F, mL/h) [Срок оценки: Day1-Day3]
  • Apparent volume of distribution (Vd/F, mL) [Срок оценки: Day1-Day3]
  • Anti-drug antibody (ADA) prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit [Срок оценки: Day1-Day15]

Критерии участия

Критерии включения

  • Healthy women of childbearing potential aged 18-55 years (inclusive) at the time of signing the Informed Consent Form (ICF);
  • Sexually active and willing to undergo vaginal administration of the study product；participants must agree to avoid the use of other intravaginal products (e.g., contraception ointments, gels, foams, sponges, lubricants, irrigation solutions, tampons, etc.) throughout the trial;
  • During the screening period, there are no clinically significant abnormalities in medical history, vital signs, physical examination, gynecological examination, laboratory test (hematology, routine urinalysis, clinical chemistry, coagulation function, vaginal microbiome test) and 12-lead ECG, or any out-of-range laboratory values or other findings must be assessed by the investigator as not clinically significant;

Критерии исключения

  • Those experiencing stinging or burning sensation, hemorrhage, pruritus, erythema, edema, or increased discharge due to previous or current use of vaginal preparations, or those with any factors that possibly have an impact on evaluation of administration site irritation, or those with other factors that may have an impact on vaginal administration, such as genital malformation;
  • Serious infections, chronic infections, opportunistic infections, etc. within 3 months prior to screening, and infections treated with systemic antimicrobial drugs (including but not limited to viruses, bacteria, fungi, and parasitic infections) within 4 weeks prior to randomization;
  • Surgical history: a. vaginal, pelvic or cervical surgery within 90 days prior to screening or planning to undergo surgery during the study; b. hysterectomy; c. other major surgery within 30 days prior to screening or planning to undergo other surgeries during the study;

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Huashan Hospital Fudan University — Шанхай

Идентификаторы

NCT: NCT07302035 · GenSci142-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗