Chlorhexidine and/or metronidazole plus FB301 pre-treatment trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Freya Biosciences ApS

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

23 Mar 2026 → ongoing

Decision date (initial)

2026-02-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the impact on change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with BV.

Secondary objectives 5

1. To assess the impact on change in microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with BV.
2. To assess the change in vaginal microbiome in terms of combined vaginal Lactobacillus crispatus, jensenii, mulieris, gasseri and paragasseri with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with BV.
3. To evaluate the presence of BV- associated bacteria Bifidobacterium spp. (previously Gardnerella spp.), Atopobium spp., and Fannyhessea spp., with and without pre-treatment with chlorhexidine antisepsis (0.5%) and/or oral metronidazole followed by administration of FB301 in women with BV.
4. To assess the safety and tolerability of FB301 with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with BV.
5. To assess the impact on rate of cure of BV with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with BV.

Conditions and MedDRA coding

Bacterial vaginosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Premenopausal women aged 18 to 45 years of age inclusive, at the time of signing the informed consent.
2. Participants with an untreated suspected or confirmed symptomatic BV presenting with characteristic vaginal discharge and/or fishy odor confirmed by Gram stain of the vaginal specimen having a Nugent Score of equal or above 7 at the screening visit.
3. Participant is otherwise in good physical and mental health, as determined by the Investigator.
4. BMI up to 37 kg/m2 (inclusive).
5. Premenopausal female patients Using oral, transdermal (patches), or injectable/implantable contraceptives or hormonal IUS (non-hormonal IUD is not allowed) within the last 3 months prior to screening must be willing not to change their method of contraception during the trial. OR Not using any hormonal method of contraception must be willing not to start any other method of contraception during the trial. They must use condoms after the period in which no sexual activity is allowed, i.e., following the primary evaluation timepoint at Visit 3 (Week 3) (17 days after FB301 treatment is initiated).
6. Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
7. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of a long-acting progestin or continuous use of oral contraceptives
8. Willing to be asked questions about reproductive/sexual activity and use of vaginal products.
9. Willing to provide and self-collect cervicovaginal secretions and vaginal swab samples at the clinic and at home.
10. Willing to undergo vaginal cleansing and treatment procedures, including self-administration of IMP, where required, at home.
11. Willing to abstain from vaginal intercourse, following the first FB301 treatment until the primary evaluation timepoint at Visit 3 (Week 3) (17 days after FB301 treatment is initiated).
12. Willing to abstain from using insertive vaginal feminine products (i.e., tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the Investigator following the first FB301 treatment until the primary evaluation timepoint at Visit 3 (Week 3) (17 days after FB301 treatment is initiated).
13. Willing and able to comply with trial procedures and attending scheduled visits.
14. No changes in medical conditions or prior/concomitant therapy also regarding adherence to sexual behavior and contraceptive/barrier requirements.

Exclusion criteria 31

1. Known immunodeficiency conditions, including drug induced.
2. Contraindication to metronidazole or chlorhexidine.
3. Any known condition requiring regular use of antibiotics, which would suggest the likely requirement for antibiotic treatment during the trial.
4. Any social, medical, or psychiatric condition that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial requirements or might interfere with the objectives of the trial.
5. History of drug or alcohol abuse that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial or would complicate interpretation of data from participation.
6. History of gynecological cancers, gynecological conditions, or surgical gynecological medical history which, in the opinion of the Investigator, precludes participation.
7. Abnormal finding on the physical examination or gynecological examination or any other condition which, in the opinion of the Investigator, precludes participation.
8. Patients with other infectious causes of vulvovaginitis (e.g., vulvovaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, or active Herpes simplex [including PCR test positive]).
9. Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical response.
10. Participants taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 2 weeks or 5 half-lives (whichever is longer) before the start of trial treatment (unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial).
11. Receiving treatment involving investigational drugs. Any previous investigational drug must have been completed at least 30 days prior to screening in this trial.
12. Systemic and/or vaginally applied antibiotic use within the last 30 days prior to screening.
13. Participants who are currently receiving antibacterial therapy unrelated to BV.
14. Clinical laboratory test results which are clinically unacceptable at screening. Any clinically significant abnormal urinalysis should be repeated. If then confirmed abnormal and clinically significant, participant should be excluded. Any clinically significant out of range chemistry or hematology values should exclude the participant.
15. Positive serum HBsAg (other than vaccination related), HCV and HIV antibody tests at screening.
16. Positive test for Treponema pallidum (syphilis).
17. Clinically relevant abnormalities in blood pressure and pulse rate (as assessed by the Investigator).
18. Aural body temperature of < 35.5 or > 37.6°C at screening.
19. Pregnant, breastfeeding, has been pregnant within the last 2 months, or wishes to become pregnant within the next 6 months. Egg donation during the trial is not permitted.
20. Use of a copper IUD (intrauterine device) within 12 weeks of screening. (Hormonal IUDs are permitted.)
21. Use of probiotics, prebiotics or symbiotics (supplements and products, oral or vaginal) within past 30 days. (NOTE: Oral yogurt with live cultures is allowed, as are fermented foods).
22. Donation of more than 100 mL whole blood or plasma within 4 weeks before start of treatment or more than 500 mL of whole blood 3 months before start of treatment or intended blood donation during the trial.
23. History of alcohol or substance dependency.
24. Employee of the Sponsor, the CRS Group, or other CRO involved in the clinical trial.
25. Any other conditions or factors which in the opinion of the Investigator may interfere with trial conduct.
26. Changes in medical conditions compared to screening which would lead to the exclusion of the participant, as assessed by the Investigator.
27. Changes in prior/concomitant therapy compared to screening, as judged by the Investigator.
28. Positive screen for alcohol or drugs of abuse on the first dosing day.
29. Clinically relevant abnormalities in blood pressure and pulse rate (as assessed by the Investigator).
30. Aural body temperature of < 35.5 or > 37.6°C on Day 1.
31. Any other conditions or factors which in the opinion of the Investigator may interfere with trial conduct.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (Baseline) to Visit 3 (Week 3).

Secondary endpoints 5

1. The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species, measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10).
2. The change in vaginal microbiome in terms of relative abundance of combined vaginal Lactobacillus crispatus, jensenii, mulieris, gasseri and paragasseri measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit 3 (Week 3), Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10).
3. The change in vaginal microbiome in terms of relative abundance of Bifidobacterium spp. (previously Gardnerella spp.), Atopobium spp., and Fannyhessea spp. measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit 3 (Week 3), Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10).
4. Frequency and intensity of all AEs including frequency and grade of the AESIs. Clinically significant changes in clinical chemistry and hematology will also be evaluated.
5. Proportion of participants with microbiological cure defined as Nugent Score of less than 4 at Visit 3 (Week 3), Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10). Proportion of participants with clinical cure, defined as resolution of abnormal vaginal discharge, negative Whiff test, pH and presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount at Visit 3 (Week 3), Visit 5 (Week 7), and Visit 6 (Week 10).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Freya Biosciences ApS

Sponsor organisation

Freya Biosciences ApS

Address

Fruebjergvej 3

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Freya Biosciences ApS

Contact name

Clinical Department

Public contact point

Organisation

Freya Biosciences ApS

Contact name

Clinical Department

Third parties 7

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications