Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000862842
Ethics application status
Approved
Date submitted
3/06/2021
Date registered
5/07/2021
Date last updated
21/09/2023
Date data sharing statement initially provided
5/07/2021
Date results information initially provided
21/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Vaginal Pharmacokinetics of Intravaginal Low Iron Lactoferrin
Scientific title
Safety and Vaginal Pharmacokinetics of Bilayer Low Iron MTbLF Vaginal Tablets in Healthy Women
Secondary ID [1] 304276 0
Protocol MT300V-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Vaginosis 322004 0
Condition category
Condition code
Infection 319723 319723 0 0
Studies of infection and infectious agents
Renal and Urogenital 319724 319724 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320615 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327614 0
Assessment of Low Iron MTbLF concentrations in vaginal fluid using standard laboratory methods. Vaginal fluid will be isolated from vaginal swabs and analyzed by high performance liquid chromatography (HPLC) to determine concentrations of Low Iron MTbLF.
Timepoint [1] 327614 0
Prior to the first dosing on Day 1 and, at 1 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours post dose on Days 1, 2 and 3 and 30 hours post 3rd dose on Day 4.
Primary outcome [2] 327615 0
Assessment of Low Iron MTbLF concentrations in blood samples using standard laboratory methods. Levels of MTbLF will be quantified in plasma using an enzyme-linked immunosorbent assay (ELISA) specific for bovine lactoferrin.
Timepoint [2] 327615 0
Prior to the first dosing on Day 1. On Days 1, 2 and 3 at 2 hours, 8 hours, 12 hours, and 24 hours post dose.
Primary outcome [3] 327616 0
Assessment of safety through medical review of adverse events and serious adverse events, physical and abbreviated gynecological examinations, vital signs and clinical laboratory tests. While there are no known identified or potential risks with the use of MTbLF intravaginally, patients will be closely monitored for safety and tolerability.
Timepoint [3] 327616 0
Adverse events will be assessed from the time the patient provides informed consent through the end of the study on Day 4. Serious adverse events will be assessed from the time the patient provides informed consent until 30 days after the last dose. Physical examination will take place at screening visit and at final visit, 4 days post initial dose. Abbreviated gynecological examination will take place at screening visit, at admission day (Day -1) and at final visit (Day 4). Vital signs will take place at screening visit, admission day (Day -1), prior to dosing on Day 1 and Day 4. Clinical laboratory tests will take place at screening visit, admission day (Day -1) and at Day 4.
Secondary outcome [1] 395945 0
Assessment of the vaginal microbiota by a PCR-based in vitro diagnostic of BV (AusDiagnostics Vaginosis and Vaginitis PCR test). The remainder of the sample will be stored for potential future analysis of the full vaginal microbiota using 16S rRNA gene sequencing.
As an exploratory analysis, vaginal fluid from this swab will also be analysed by LC-MS to examine the vaginal metabolome.
Timepoint [1] 395945 0
At admission day (Day -1), at T=0 hours (pre-dose) on Days 1, 2 and 3 and on Day 4, around 30 hours post 3rd dose.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/11/2021
Actual
8/11/2021
Date of last participant enrolment
Anticipated
Actual
26/11/2021
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
6
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308653 0
Commercial sector/Industry
Name [1] 308653 0
Metrodora Therapeutics Pty Ltd
Country [1] 308653 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Metrodora Therapeutics Pty Ltd
Address
Level 7, 330 Collins Street, Melbourne Victoria 3000, Australia
Country
Australia
Secondary sponsor category [1] 309547 0
None
Name [1] 309547 0
Address [1] 309547 0
Country [1] 309547 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308579 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 308579 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 308579 0
Australia
Date submitted for ethics approval [1] 308579 0
02/06/2021
Approval date [1] 308579 0
15/07/2021
Ethics approval number [1] 308579 0

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111210 0
Dr Philip Ryan
Address 111210 0
Nucleus Network Pty Ltd
Level 5
89 Commercial Road
Melbourne, VIC 3004
Country 111210 0
Australia
Phone 111210 0
+61 438 009 787
Fax 111210 0
Email 111210 0
p.ryan@nucleusnetwork.com.au
Contact person for public queries
Name 111211 0
Dr Philip Ryan
Address 111211 0
Nucleus Network Pty Ltd
Level 5
89 Commercial Road
Melbourne, VIC 3004
Country 111211 0
Australia
Phone 111211 0
+61 438 009 787
Fax 111211 0
Email 111211 0
p.ryan@nucleusnetwork.com.au
Contact person for scientific queries
Name 111212 0
Dr Gary Gelbfish
Address 111212 0
Metrodora Therapeutics
2502 Avenue I,
Brooklyn, NY 11210
USA
Country 111212 0
United States of America
Phone 111212 0
+19176136162
Fax 111212 0
Email 111212 0
ggelbfish@metrodora.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.