None listed
Conditions
Brief summary
This research study in BV patients is testing the safety, tolerability, pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a formulation of a drug called Metrodora Therapeutics bovine Lactoferrin (MTbLF) when it is given Intravaginally (into the vagina). Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of Bacterial Vaginosis (BV). The overall goal of this study is to optimize the formulation to test in future studies as a treatment for BV. BV patients will receive 10 daily doses of study medication; 3 doses of a single formulation in the clinical unit separated by 24 hours in consecutive days of their preference and the remaining days, they will self-administer the same formulation daily. A series of vaginal swabs and blood samples will be collected over a 24-hour period following each of the two first doses in clinic, once approximately 12 hours after the third in-clinic dose and after each home dosing and at the Follow Up visit 21 to 35 days after first dose of study medication .
Interventions
Metrodora Therapeutics bovine Lactoferrin [MTbLF] will be administered intravaginally (into the vagina) using a single use applicator. The formulation contains 300 mg of MTbLF (bovine lactoferrin) along with filler, thickener, mucoadhesive gelling agent, glidant and lubricant (excipients). The excipients are all compendial inactive ingredients commonly used in vaginally administered products. Patients will receive 10 daily doses of study medication. Patients will receive 3 doses of a single form
Metrodora Therapeutics bovine Lactoferrin [MTbLF] will be administered intravaginally (into the vagina) using a single use applicator. The formulation contains 300 mg of MTbLF (bovine lactoferrin) along with filler, thickener, mucoadhesive gelling agent, glidant and lubricant (excipients). The excipients are all compendial inactive ingredients commonly used in vaginally administered products. Patients will receive 10 daily doses of study medication. Patients will receive 3 doses of a single formulation in the clinical unit administered by a healthcare practitioner separated by 24 hours in consecutive days of their preference. The remaining days, they will self-administer the same formulation daily at home. Adherence to dosing will be monitored by clinical personnel over the course of the 3 nights/2 days in-clinic treatment period and by monitoring a patient home dosing record along with counting tablets during the at home dosing period.
Sponsors
Metrodora Therapeutics Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. In Part 1 and Part 2, premenopausal healthy females or pre-menopausal females with asymptomatic BV age 18 - 50 years old. In Part 3, pre-menopausal females with symptomatic BV age 18 - 45 years old who test positive for BV (AusDiagnostics Vaginitis and Vaginosis PCR test of “Flora consistent with Bacterial Vaginosis”) 2. Able to understand and sign informed consent form prior to initiation of any study-related procedures 3. Able to commit to in-clinic monitoring over a 3-night period for scheduled visits and assessments 4. Able to return to the clinic daily for scheduled assessments for the 7 days of home dosing and for a Follow Up Visit 21 to 35 days after first dose of study medication 5. Willing to abstain from sexual activity 24 hours before dosing and Day -1 through Day 11 6. Body Mass Index (BMI) range of 18-35.0
Exclusion criteria
1. Currently pregnant or lactating 2. Menopausal 3. Anticipate menstruation to occur during the in-clinic period of the study 4. Women with with greater than or equal to 4 episodes of treatment for symptomatic vaginal infections during the past year (women with a history of BV are allowed) 5. Currently receiving, or requiring during the study, other intravaginal treatment of any kind (e.g., tablet, suppository, cream, gel, foam, vaginal ring, douching, 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. HIV positive or has previously tested positive for any STD within the last 30 days 9. Test positive by AusDiagnostics Vaginitis and Vaginosis PCR test at screening for trichomoniasis or candidiasis 10. Diagnosis of cervical intra-epithelial neoplasia or cervical carcinoma 11. Any abnormal anatomy or pathology of the vagina 12. Taking concomitant diuretics 13. History of allergy to bovine milk, bovine milk products, lactoferrin, or components of the MTbLF Drug Product. 14. 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. 15. Regular smokers unwilling to abstain from smoking for the duration of the 3-day in-clinic part of the study. Subjects who smoke but are willing and able to abstain for the 3-day in-clinic study duration can be included. 16. Asthma requiring preventer medication. Subjects with mild asthma requiring an occasional reliever inhaler can be included.
Outcome results
None listed