CTRI/2025/01/079802已完成1 期
A Phase I Clinical Study to Evaluate the Safety and Pharmacokinetics of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult Female Subjects
Viridis BioPharma Pvt Ltd1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年2月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The assessment of safety and tolerability will be based on the frequency of adverse events and local tolerance.
研究概览
简要总结
A Phase I Clinical Study to Evaluate the Safety and Pharmacokinetics of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult Female Subjects.
Study objective:
Primary objective: The primary objective of the study is to assess the safety of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult female subjects.
Secondary objective: The secondary objective of the study is to assess the Pharmacokinetics of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult female subjects.
Study endpoint:
-The assessment of safety and tolerability will be based on the frequency of adverse events and local tolerance.
-Pharmacokinetic evaluation of Colloidal Nano Silver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy Adult female subjects between 18 to 40 years of age (Both Inclusive).
- •Body Mass Index (BMI) between 18.50–30.00 Kg/m
- •Healthy female subjects as evaluated by personal history, medical history, medical examination, and gynaecological examination at screening visit.
- •Subjects with normal menstrual history with regular cycles with a minimum of 21 days between menses.
- •Volunteer with Laboratory evaluations within normal range or clinically non-significant at screening visit.
- •Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen and Hepatitis C antibody.
- •Normal PAP smear result.
- •Volunteer who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- •Volunteer who can provide adequate evidence of their identity.
- •Volunteer who are willing to abstain from sexual intercourse or use a reliable method of contraception during the study.
- •Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test performed within 21 days prior to initiation of the study.
排除标准
- •History of or known sensitivity/allergy to any component of study product.
- •Volunteer Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 3 months.
- •Volunteer with Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening.
- •Presence of any clinically significant genital epithelial findings such as abrasions, ulcerations, lacerations at screening.
- •Have an abnormal PAP test performed at the time of screening.
- •Presence of any other clinically significant abnormal physical finding on the vulva, vaginal walls or cervix at screening.
- •Volunteer with any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major diagnosed disease or malignancy.
- •History of hysterectomy or menopause.
- •History of gynaecological surgery or procedure within past 2 months.
- •Received systemic or intravaginal antifungal, antibacterial or anti-parasitic drugs within 14 days prior to the first application of study medication.
- •History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months, including break-through bleeding requiring sanitary protection.
- •Known history of HIV, HCV and HBsAg.
- •Known current alcohol abuse and Consumption of alcohol within 48.00 hours prior to check in or difficulty in abstaining from alcohol for the duration of the study.
- •History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake during the in-house stay and history of consumption of caffeine and /or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for at least 24.00 hours prior to check-in.
- •History of Consumption of tobacco and tobacco containing products, grapefruit and its juices for at least 48.00 hours prior to check in.
- •Intake of OTC products, herbal medications, etc. within 7 days prior to check-in.
- •Intake of any prescription medications within 14 days prior to check-in that could affect the kinetics or dynamics of study medications in view of investigator.
- •An unusual diet for whatever reason (e.g. low sodium diet) for three weeks prior to check-in.
- •Donation or significant loss of whole blood (480 mL or more) within 30 days or serum within 14 days prior to screening.
- •Any other condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
- •Unable to comply with study requirements, including but not limited to, attending all study visits, using the gel as directed, observing abstinence throughout the study and use of effective contraceptives.
- •Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to check in.
- •Personal or family history of muscular disorders.
- •Volunteer having any deformity that will affect venous access for cannulation.
- •eGFR less than 60 ml/min.
- •Female who is pregnant or lactating, or plans to become pregnant during the study.
- •Female whose last menstrual period (LMP) is 21 days prior to initiation of study.
结局指标
主要结局
The assessment of safety and tolerability will be based on the frequency of adverse events and local tolerance.
时间窗: 15 days
次要结局
- Pharmacokinetic evaluation of Colloidal Nano Silver.(Day 1:)
研究者
Dr Deepalakshmi Rao
BioRadius Therapeutic Research Pvt. Ltd.
研究点 (1)
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