A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)

Обзор

A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).

Подробное описание

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV) aged 18 to 50 years, providing a basis for subsequent clinical development.This is a randomized, multicenter, open-label, active-controlled clinical trial. A total of approximately 30 subjects are planned for enrollment and will be randomized in a 2:1 ratio to either the treatment group or the control group.Treatment group: GenSci142. Control group: clindamycin phosphate vaginal cream.The study consists of a screening period (approximately 3 days), a treatment period (7 days), and a efficacy evaluation period (approximately 90 days), with a total of 7 scheduled visits.

Вмешательства

• Препарат GenSci142 capsule
  Vaginal administration
• Препарат clindamycin phosphate vaginal cream
  Clindamycin ointment, 5 grams, once daily for 7 days

Первичные конечные точки

• Incidence and severity of treatment-emergent adverse events [Срок оценки: From the first dose to Day 30]

Вторичные конечные точки (12)

• Clinical cure rate base on Amsel assessment [Срок оценки: from first dose of study treatment up to 21~30 days after first dose]
• Change of Nugent score from baseline [Срок оценки: from first dose of study treatment up to 2 days after first dose]
• Microbiological cure rate base on Nugent score of <4 [Срок оценки: from first dose of study treatment up to 21~30 days after first dose]
• Clinical cure rate base on Amsel assessment [Срок оценки: from first dose of study treatment up to 8~14 days after first dose]
• Microbiological cure rate base on Nugent score of <4 [Срок оценки: from first dose of study treatment up to 8~14 days after first dose]
• Rrecurrence rate (recurrence as assessed by either Amsel or Nugent score) [Срок оценки: from first dose of study treatment up to 90 days after first dose]
• Clinical recurrence rate base on Amsel assessment [Срок оценки: from first dose of study treatment up to 90 days after first dose]
• Microbiological recurrence rate base on score of >7 [Срок оценки: from first dose of study treatment up to 90 days after first dose]
• Time to clinical symptoms disappear [Срок оценки: from first dose of study treatment up to 30 days]
• Time to recurrence [Срок оценки: from first dose of study treatment up to 90 days after first dose]
• Concentrations of GenSci142 in serum samples at different time points are measured. Serum concentrations at different time points will be listed and summarized by descriptive statistics. [Срок оценки: from pre-dose up to 2 days after first dose]
• Anti-drug antibody prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit [Срок оценки: from pre-dose up to 90 days after first dose]

Критерии участия

Критерии включения

• Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);
• Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:

• At least one clinical symptom (itching, odour, abnormal vaginal discharge),
• and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),
• and a Nugent score of ≥7;
• Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;
• be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;
• Trial participants must voluntarily sign a written informed consent form prior to the trial;
• Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.

Критерии исключения

Medical History

• Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;
• Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;
• Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;
• Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;
• Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;
• Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;
• Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;
• Participants with abnormal uterine bleeding, including prolonged menstrual periods (>7 days);
• Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;
• Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;
• Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;
• Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;
• A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle
• Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;
• Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence
• History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations
• Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;
• During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;
• Participants with positive results in infectious disease screening \[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\]; Other
• Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;
• The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Beijing Tsinghua Changgung Hospital — Пекин
• Nanjing Maternity and Child Health Care Hospital — Нанкин
• Jiangxi Provincial Women and Children's Medical Center — Nanchang
• The First Hospital of Jilin University — Changchun
• Shandong Provincial Hospital — Цзинань
• The Second Hospital of Shanxi Medical University — Taiyuan
• Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07663838 · GenSci142-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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