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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05587283




Registration number
NCT05587283
Ethics application status
Date submitted
17/10/2022
Date registered
20/10/2022
Date last updated
9/03/2023

Titles & IDs
Public title
Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women
Scientific title
Phase 1 Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability and Acceptability of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Female Volunteers
Secondary ID [1] 0 0
LT-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Vaginosis 0 0
Vaginal Disease 0 0
Bacterial Infections 0 0
Vaginitis 0 0
Infection, Bacterial 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Experimental: Low dose LABTHERA-001 capsule
Treatment: Drugs - Experimental: Medium dose LABTHERA-001 capsule
Treatment: Drugs - Experimental: High dose LABTHERA-001 capsule
Other interventions - Placebo Comparator: Low dose Placebo capsule
Other interventions - Placebo Comparator: Medium dose Placebo capsule
Other interventions - Placebo Comparator: High dose Placebo capsule

Experimental: Low dose LABTHERA-001 capsule - Low dose LABTHERA-001 capsule (0.2 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days.

Experimental: Medium dose LABTHERA-001 capsule - Medium dose LABTHERA-001 capsule (1 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days.

Experimental: High dose LABTHERA-001 capsule - High dose LABTHERA-001 capsule (5 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days.

Placebo Comparator: Low dose Placebo capsule - Low dose Placebo (excipients of the study drug) capsule administered intravaginally once a day for 7 consecutive days.

Placebo Comparator: Medium dose Placebo capsule - Medium dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days.

Placebo Comparator: High dose Placebo capsule - High dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days.


Treatment: Drugs: Experimental: Low dose LABTHERA-001 capsule
Low dose LABTHERA-001 capsule, 0.2 x 10^9 CFU/capsule with excipients.

Treatment: Drugs: Experimental: Medium dose LABTHERA-001 capsule
Medium dose LABTHERA-001 capsule, 1 x 10^9 CFU/capsule with excipients.

Treatment: Drugs: Experimental: High dose LABTHERA-001 capsule
High dose LABTHERA-001 capsule, 5 x 10^9 CFU/capsule with excipients.

Other interventions: Placebo Comparator: Low dose Placebo capsule
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.

Other interventions: Placebo Comparator: Medium dose Placebo capsule
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.

Other interventions: Placebo Comparator: High dose Placebo capsule
High dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of AEs in participants throughout the study and their severity and relationship to the study product.
Timepoint [1] 0 0
35 days since the first dose administration
Primary outcome [2] 0 0
Changes in Clinical Laboratory Tests, Vital signs (body temperature, respiratory rate, heart rate, blood pressure), Gynaecological Examination, and Physical Examination.
Timepoint [2] 0 0
Baseline and each follow-up visit upto 35 days since the first dose administration (Day 1)
Secondary outcome [1] 0 0
Acceptability evaluation
Timepoint [1] 0 0
Visit 3 (Day 9)

Eligibility
Key inclusion criteria
1. Healthy non-smoking woman aged 18 to 45 years old as of the date of written consent

2. Agrees to maintain her contraceptive method during the clinical trial if she has
regular menstrual cycles (21-35 days) or has had amenorrhea for more than 12 weeks
before the Screening Visit due to continued use of long-acting progestin or oral
contraceptives.

3. Confirmed normal cervical screen test (CST) performed at the Screening Visit

4. Has had sexual experiences that included vaginal intercourse

5. Has experienced gynecological examinations previously

6. Agrees to discontinue the use of the following during the clinical trial period
(Screening Visit to End of study visit or early termination visit):

- products for vaginal insertion (e.g., tampons, menstrual cups, etc.)

- Other vaginal products (e.g., contraceptive creams, vaginal cleaners, lubricants,
etc.)

7. Agrees to be sexually abstinent from 72 hours before the Day 1 visit until the first
study visit after final administration of IP (nominally the Day 9 visit).

8. Agrees to continue to use the following highly effective contraceptive methods during
the clinical trial period and for at least 30 days after the final dose of study
treatment, if woman of child-bearing potential (has experienced menarche and is not
permanently sterile or postmenopausal):

- Female: combined (estrogen and progestogen containing) hormonal/ contraception
associated with inhibition of ovulation (oral or transdermal), progestogen-only
hormonal contraception associated with inhibition of ovulation (oral, injectable,
implantable), intrauterine device (IUD; if inserted more than 12 weeks before the
Screening visit), intrauterine hormone-releasing system (IUS), bilateral tubal
occlusion, vasectomized partner, sexual abstinence

- Male partner: 'Vasectomy,' 'condom'

9. Able and willing to insert a hard capsule into her vagina

10. Able and willing to answer questions about her health status and sexual life

11. Able and willing to undergo vaginal and cervical examinations by the Investigator

12. Agrees and can comply with the planned clinical trial procedures after receiving a
full explanation and voluntarily decides to participate and gives written informed
consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Confirmed to have the following urogenital infections from the vaginal discharge test
performed at the Screening Visit, or had the following diagnosed urogenital infections
within three weeks before the Screening Visit, or has a history of clinically
significant urogenital infections at the discretion of the Investigator:

• Urinary tract infection, bacterial vaginosis, candida vaginitis, trichomonas
vaginalis, Neisseria gonorrhoeae, chlamydia trachomatis, treponema pallidum, herpes
simplex

2. History of recurrent genital herpes

3. Has the following diagnosed urogenital infections, or had two or more clinically
significant urogenital infections within 24 weeks before the Screening Visit, at the
discretion of the Investigator:

• [Gonococcus, chlamydia trachomatis, syphilis treponema, trichomonas vaginitis,
candida vaginitis, etc.]

4. Has vaginitis symptoms (abnormal vaginal discharge, itching, burning sensation, etc.)
at Screening or pre-dose at the Day 1 visit, or between the Screening and Day 1
visits.

5. Is pregnant, lactating, within eight weeks of childbirth, or is planning pregnancy
within 60 days of the last dose of IP.

6. Is menopausal, defined as being amenorrhoeic for at least 12 months without an
alternative cause.

7. Has had an intrauterine device (IUD) inserted within 12 weeks before the Screening
Visit

8. Underwent pelvic surgery within 12 weeks before the Screening Visit

9. Received cervical cryotherapy or cervical laser treatment within 12 weeks before the
Screening Visit

10. Started to use long-acting hormonal contraceptives within 12 weeks before the
Screening Visit [e.g., DMPA (depot formulation including medroxyprogesterone acetate)]
(However, participants who have continuously used the contraceptive for more than 12
weeks can be enrolled at the discretion of the Investigator.)

11. Has a clinically significant medical history or current medical condition as assessed
by the Investigator including but not limited to the cardiovascular system,
respiratory system, kidney, endocrine system, hematology, digestive system, central
nervous system, psychiatric disorder, or infectious disease, that may affect the
safety evaluation of the investigational product or jeopardize the individual's
involvement in the study. History of any cancer (including non-melanoma skin cancer)
is exclusionary.

12. Positive test for SARS-CoV-2 (COVID-19) during the Screening period and pre-dose at
the Day 1 visit (may be re-screened when eligible).

13. Positive diagnosis of human immunodeficiency virus (HIV), hepatitis B or C at the
Screening Visit

14. Confirmed to have severe damage to the vaginal epithelium in the physical examination
at the Screening Visit

15. Used immunosuppressants within four weeks before the Screening Visit

16. Used antibiotics or antifungals within three days before the Screening Visit (However,
enrollment is possible if the individual agrees to a washout period equivalent to
three times or more the half-life of the corresponding drugs as of the randomization
date.)

17. History of hypersensitivity reactions to the components of the study drug or history
of other serious drug hypersensitivity reactions, at the discretion of the
Investigator

18. History of or current drug or alcohol abuse; or tests positive to urine drug screen or
alcohol breath test at the Screening or Day 1 visits; or does not agree to abstain
from alcohol 24 hours before each study visit and to consume no more than 10 standard
drinks per week with no more than 4 standard drinks on any one day at any other time
during their participation in the study. One standard drink contains 10 g alcohol.
Urine drug screen may be repeated once only at the discretion of the Investigator.

19. Current tobacco smoker; or smoked more than one pack of cigarettes (or tobacco
equivalent) per day for more than 10 years; or uses nicotine-replacement therapy
(including vaping); or does not agree to abstain from using tobacco or
nicotine-containing products during the study.

20. Received other investigational products within four weeks before the Screening Visit

21. Received COVID-19 vaccination or any other vaccination within 8 weeks before the first
dose of IP, and/or is planning or scheduled to be vaccinated (including COVID-19
initial, second or booster dose) during the study period up to the final follow-up
visit.

22. Judged by the Investigator to be unsuitable for participation in this clinical trial.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AtoGen Co. Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ATOGEN AUSTRALIA PTY LTD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose
escalation, clinical trial enrolling 24 healthy participants. The main subject is to
investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the
acceptability of the capsule.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05587283
Trial related presentations / publications
Mastromarino P, Vitali B, Mosca L. Bacterial vaginosis: a review on clinical trials with probiotics. New Microbiol. 2013 Jul;36(3):229-38. Epub 2013 Jun 30.
Kenyon C, Colebunders R, Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol. 2013 Dec;209(6):505-23. doi: 10.1016/j.ajog.2013.05.006. Epub 2013 May 6.
Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
Vicariotto F, Mogna L, Del Piano M. Effectiveness of the two microorganisms Lactobacillus fermentum LF15 and Lactobacillus plantarum LP01, formulated in slow-release vaginal tablets, in women affected by bacterial vaginosis: a pilot study. J Clin Gastroenterol. 2014 Nov-Dec;48 Suppl 1:S106-12. doi: 10.1097/MCG.0000000000000226.
De Seta F, Parazzini F, De Leo R, Banco R, Maso GP, De Santo D, Sartore A, Stabile G, Inglese S, Tonon M, Restaino S. Lactobacillus plantarum P17630 for preventing Candida vaginitis recurrence: a retrospective comparative study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:136-9. doi: 10.1016/j.ejogrb.2014.09.018. Epub 2014 Sep 17.
Strus M, Chmielarczyk A, Kochan P, Adamski P, Chelmicki Z, Chelmicki A, Palucha A, Heczko PB. Studies on the effects of probiotic Lactobacillus mixture given orally on vaginal and rectal colonization and on parameters of vaginal health in women with intermediate vaginal flora. Eur J Obstet Gynecol Reprod Biol. 2012 Aug;163(2):210-5. doi: 10.1016/j.ejogrb.2012.05.001. Epub 2012 Jun 19.
Hemalatha R, Mastromarino P, Ramalaxmi BA, Balakrishna NV, Sesikeran B. Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study. Eur J Clin Microbiol Infect Dis. 2012 Nov;31(11):3097-105. doi: 10.1007/s10096-012-1671-1. Epub 2012 Jul 10.
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Argent, Dr.
Address 0 0
Scientia Clinical Research Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Scientia Clinical Research Study Team
Address 0 0
Country 0 0
Phone 0 0
+61 02 9382 5800
Fax 0 0
Email 0 0
christopher.argent@scientiaclinicalresearch.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05587283