Safety and Tolerability Studies of CanProFem-AK, Vaginal Suppositories in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- General indicators for safety evaluation of a studied drug:
研究概览
简要总结
The study object of this clinical trial is CanProFem-AK, 100 mg suppositories. The Pharmacological group - Antifungal drug for external use. The active drug substance is the antifungal antibiotic Roseofungin 100 mg, which was developed at the "Research and Production Center of Microbiology and Virology".
According to the aims and objectives of the phase I clinical trial, the primary parameter is the study of safety and tolerability throughout the entire duration of the trial.
The phase I clinical trial of the drug CanProFem-AK 100 mg included 20 healthy female participants aged 18 to 40 years, who are on 6-12 days of their menstrual cycle. The clinical and laboratory parameters to characterize the safety of the drug: specific clinical signs and symptoms of particular importance, medical history, physical examination, biochemical analysis of blood, complete blood count with white blood cell count, and complete urine analysis.
Selection and Exclusion of Subjects: Before inclusion in a clinical trial, each participant must first sign an Informed Consent Form for Participation in the Study, followed by a screening examination, including a variety of procedures, medical history, and physical examination. Each participant in the trial will be assigned an identification number.
Study Design: open-label, single-centre, phase I clinical trial. The total duration of participation in a study is one day. The administration scheme of the drug includes the vaginal insertion of one suppository for each participant, followed by medical observation of the participants' conditions at 3, 6, 9, 12 and 24 hours after administration.
The tolerability of the drug will be assessed based on the reported participants' symptoms and sensations, and objective data obtained by the researcher during the study. The frequency and nature of adverse reactions will also be taken into account. The degree of tolerability of the study drug will be determined by three gradations: intolerance, absence of adverse drug reactions (side reactions), and adverse drug reactions (side effects) not classified as serious.
This clinical trial will be conducted following the principles formulated by the 18th World Medical Assembly (Helsinki, 1964) and the ICH guidelines for good clinical practice (GCP), as well as with all international and national laws and guidelines.
详细描述
The study object of this clinical trial is CanProFem-AK, 100 mg suppositories. The Pharmacological group - Antifungal drug for external use.
Fungal infections are one of the most demanding and unresolved problems of modern medicine. The number of fungal infections is growing due to the increase in the number of people with immunodeficiency diseases, oncohematological pathology, organ transplants, nursing newborns, the coronavirus pandemic, while the role of fungi that were previously considered non-pathogenic is increasing. Among fungal diseases, candidiasis, caused by fungi of the genus Candida, is of particular importance. Genital, vulvovaginal, candidiasis is a very common phenomenon. Taking into account the prevalence of candidiasis, as well as numerous cases of resistance of pathogenic fungi to drugs, an urgent task is to create new domestic effective antifungal drugs for their treatment.
Scientists from the "Research and Production Center of Microbiology and Virology" developed a new pharmaceutical antifungal drug "CanProFem-AK"® in the form of a suppository for the treatment of vaginal candidal infections. The active drug substance is the original antifungal antibiotic Roseofungin, produced by a strain of soil microorganism, that has high activity against pathogenic fungi - causative agents of human mycoses. Preclinical trials of the drug shown its safety and effectiveness in the treatment of vaginal candidiasis. The trials demonstrated that the drug exhibits high antifungal activity, therapeutic efficacy, and safety in use.
The phase I clinical trial of the drug CanProFem-AK 100 mg included 20 healthy female participants aged 18 to 40 years, who are on 6-12 days of their menstrual cycle. The clinical and laboratory parameters to characterize the safety of the drug were: specific clinical signs and symptoms of particular importance, medical history, physical examination, biochemical analysis of blood, complete blood count with white blood cell count, and complete urine analysis.
Study design: open-label, single-centre, phase I clinical trial. Dosage regimen: vaginal administration of one suppository of the studied drug (CanProFem-AK, 100 mg). The total duration of participation in a study is one day. The administration scheme of the drug includes the vaginal insertion of one suppository for each participant, followed by medical observation of the participants' conditions at 3, 6, 9, 12 and 24 hours after administration. Repeated blood and urine laboratory tests will be performed after 24 hours. Participants of the study will be closely monitored for 24 hours after the initial administration of the drug to detect any immediate adverse events. If the subject experiences an immediate adverse event, appropriate treatment will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers aged 18-40 years with verified health status and no chronic or acute systemic or dermatological diseases.
- •Willingness to voluntarily participate in the study.
排除标准
- •Individuals with chronic diseases (tuberculosis, hepatitis, HIV infection, diabetes mellitus, cancer), chronic renal failure, chronic liver failure, exacerbations of chronic diseases;
- •Individuals participating in parallel clinical trials of other drugs, or who participated within 3 months from the start of the current study;
- •Individuals from the category of "vulnerable patients" (homeless, military personnel, incapacitated persons, patients in emergency situations, and other individuals who may be the subject of pressure);
- •Patients with an allergy in their medical history and during screening (medicinal, pollen and other types);
- •Patients with a history of oncopathology or a family history of oncopathology (the presence of oncopathology among close relatives);
- •Patients with hypersensitivity to one of the components of the study drug;
- •Pregnancy and breastfeeding;
- •Patient's refusal to perform the procedures required by the protocol and inability to adhere to the procedure schedule.
研究组 & 干预措施
Healthy Volunteers
The drug administration scheme involves vaginal administration of one suppository (CanProFem-AK, 100 mg). The total duration of participation in a study is one day.
干预措施: CanProFem-AK (Drug)
结局指标
主要结局
General indicators for safety evaluation of a studied drug:
时间窗: 24 hours
* Absence of allergic reactions and clinically significant changes in blood count * Analysis of biochemical blood test indicators * Complete blood count with white blood cell count, and complete urine analysis * Absence of changes in the general somatic condition of volunteers during the study period (physical examination). Absence of side effects.
Tolerability of the studied drug
时间窗: 24 hours
The degree of tolerability of the studied drug will be determined by three gradations: * Intolerance: The appearance of local signs of allergy/pseudoallergy and systemic signs, such as tachycardia (heart rate over 90 per minute for 30 minutes after administration), decreased blood pressure (less than 100/60 mm Hg for 30 minutes after application), or serious adverse drug reactions. * Absence of adverse drug reactions (side effects). * Adverse drug reactions (side effects) not classified as serious.
次要结局
未报告次要终点