None listed
Conditions
Brief summary
This research study in healthy subjects is testing the safety, tolerability, and pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a bilayer tablet formulation of a drug called Metrodora Therapeutics Low Iron bovine Lactoferrin (Low Iron MTbLF) when it is given Intravaginally (into the vagina) as a bilayer tablet. 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 or prevention of recurrence of BV. Healthy subjects will receive 3 doses of study medication in the clinical unit separated by 24 hours on consecutive days of their preference . A series of vaginal swabs and blood samples will be collected over a 24-hour period following each of the three doses in clinic and once on the final day of the study (Day 4).
Interventions
Metrodora Therapeutics Low Iron bovine Lactoferrin [Low Iron MTbLF] will be administered as a bilayer tablet intravaginally (into the vagina) using a single use applicator. Each tablet contains 300 mg of Low Iron MTbLF (bovine lactoferrin). Subjects will receive 3 doses of study medication separated by 24 hours on consecutive days in the clinical unit administered by a healthcare practitioner. Adherence to dosing will be monitored by clinical personnel over the course of the 4 nights/3 days in-
Metrodora Therapeutics Low Iron bovine Lactoferrin [Low Iron MTbLF] will be administered as a bilayer tablet intravaginally (into the vagina) using a single use applicator. Each tablet contains 300 mg of Low Iron MTbLF (bovine lactoferrin). Subjects will receive 3 doses of study medication separated by 24 hours on consecutive days in the clinical unit administered by a healthcare practitioner. Adherence to dosing will be monitored by clinical personnel over the course of the 4 nights/3 days in-clinic treatment 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 50 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed