ACTRN12621000862842已完成1 期
Safety and Vaginal Pharmacokinetics of Bilayer Low Iron MTbLF Vaginal Tablets in Healthy Women
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- Female
入选标准
- •1.Premenopausal healthy females age 18 - 50 years old
- •2.Able to understand and sign informed consent form prior to initiation of any study-related procedures
- •3.Able to commit to in-house monitoring over a 4-day period for scheduled visits and assessments
- •4.Willing to abstain from sexual activity 24 hours before dosing and Day -1 through Day 4
- •5.Body Mass Index (BMI) range of 18 to 35.0.
排除标准
- •1. Currently pregnant or lactating
- •2. Menopausal
- •3. Anticipate menstruation will occur during the 4 day period of the study
- •4. Women in whom gynecological examinations with a speculum are deemed inappropriate (e.g., women never sexually active)
- •5. Currently receiving, or requiring during the study, other intravaginal treatment of any kind (e.g., tablet, suppository, cream, gel, foam, vaginal ring, etc.). Intrauterine devices (e.g., IUD) are acceptable.
- •6. Gynecologic surgery in past 3 months
- •7. Received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days prior to study drug administration.
- •8. Received COVID-19 vaccine within 14 days prior to study drug administration.
- •9. Symptomatic BV requiring treatment
- •10. Positive for HIV or Hepatitis B or C, or herpes simplex virus active lesions at screening, or has previously tested positive for any STD within the last 30 days
- •11. Participant has a positive test result for substance abuse at Screening or Day-1 (i.e., alcohol, amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol)
- •12. Diagnosis or history of cervical intra-epithelial neoplasia or cervical carcinoma
- •13. Any abnormal anatomy or pathology of the vagina
- •14. Taking concomitant diuretics
- •15. History of allergy to bovine milk, bovine milk products, lactoferrin, or components of the MTbLF Drug Product.
- •16. Received another investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is greater, or planned receipt of an investigational agent not specified by this protocol during the study period.
- •17. Regular smokers unwilling to abstain from smoking for the duration of the 4-day study. Subjects who smoke but are willing and able to abstain for the 4-day study duration can be included. The use of nicotine-based products (i.e., patches, gum) is allowed.
- •18. Asthma requiring preventer medication. Subjects with mild asthma requiring an occasional reliever inhaler can be included.
研究者
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