Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women

NCT05587283 | Unknown Phase 1 DMC

• 1 other identifier: LT-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis; Vaginal Disease; Bacterial Infections; Vaginitis; Infection, Bacterial

Keywords

LBP

Outcome Measures

Primary Outcomes (2)

• Number of AEs in participants throughout the study and their severity and relationship to the study product.

  Any incidence of adverse events will be evaluated for their severity and relationship to the study product. The number of AEs and other combined measurement results will be evaluated for the safety of the study product.

  35 days since the first dose administration

• Changes in Clinical Laboratory Tests, Vital signs (body temperature, respiratory rate, heart rate, blood pressure), Gynaecological Examination, and Physical Examination.

  Day 1 pre-dose results will be used as the baseline values. Abnormalities in clinical laboratory parameters, gynaecological examination findings, and vital signs will be based on predefined normal ranges and will be tabulated by dose group showing participant counts and percentages.

  Baseline and each follow-up visit upto 35 days since the first dose administration (Day 1)

Secondary Outcomes (1)

• Acceptability evaluation

  Visit 3 (Day 9)

Study Arms (6)

Low dose LABTHERA-001 capsule

EXPERIMENTAL

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

Drug: Experimental: Low dose LABTHERA-001 capsule

Medium dose LABTHERA-001 capsule

EXPERIMENTAL

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

Drug: Experimental: Medium dose LABTHERA-001 capsule

High dose LABTHERA-001 capsule

EXPERIMENTAL

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

Drug: Experimental: High dose LABTHERA-001 capsule

Low dose Placebo capsule

PLACEBO COMPARATOR

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

Other: Placebo Comparator: Low dose Placebo capsule

Medium dose Placebo capsule

PLACEBO COMPARATOR

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

Other: Placebo Comparator: Medium dose Placebo capsule

High dose Placebo capsule

PLACEBO COMPARATOR

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

Other: Placebo Comparator: High dose Placebo capsule

Interventions

Experimental: Low dose LABTHERA-001 capsule DRUG

Low dose LABTHERA-001 capsule, 0.2 x 10\^9 CFU/capsule with excipients.

Also known as: Lactobacillus Plantarum ATG-K2

Low dose LABTHERA-001 capsule

Experimental: Medium dose LABTHERA-001 capsule DRUG

Medium dose LABTHERA-001 capsule, 1 x 10\^9 CFU/capsule with excipients.

Also known as: Lactobacillus Plantarum ATG-K2

Medium dose LABTHERA-001 capsule

Experimental: High dose LABTHERA-001 capsule DRUG

High dose LABTHERA-001 capsule, 5 x 10\^9 CFU/capsule with excipients.

Also known as: Lactobacillus Plantarum ATG-K2

High dose LABTHERA-001 capsule

Placebo Comparator: Low dose Placebo capsule OTHER

Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.

Also known as: Control substance

Low dose Placebo capsule

Placebo Comparator: Medium dose Placebo capsule OTHER

Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.

Also known as: Control substance

Medium dose Placebo capsule

Placebo Comparator: High dose Placebo capsule OTHER

High dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.

Also known as: Control substance

High dose Placebo capsule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy non-smoking woman aged 18 to 45 years old as of the date of written consent
• 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.
• Confirmed normal cervical screen test (CST) performed at the Screening Visit
• Has had sexual experiences that included vaginal intercourse
• Has experienced gynecological examinations previously
• 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.)
• 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).
• 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'
• Able and willing to insert a hard capsule into her vagina
• Able and willing to answer questions about her health status and sexual life
• Able and willing to undergo vaginal and cervical examinations by the Investigator

You may not qualify if:

• 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
• History of recurrent genital herpes
• 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:
• \[Gonococcus, chlamydia trachomatis, syphilis treponema, trichomonas vaginitis, candida vaginitis, etc.\]
• 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.
• Is pregnant, lactating, within eight weeks of childbirth, or is planning pregnancy within 60 days of the last dose of IP.
• Is menopausal, defined as being amenorrhoeic for at least 12 months without an alternative cause.
• Has had an intrauterine device (IUD) inserted within 12 weeks before the Screening Visit
• Underwent pelvic surgery within 12 weeks before the Screening Visit
• Received cervical cryotherapy or cervical laser treatment within 12 weeks before the Screening Visit
• 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.)
• 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).
• Positive diagnosis of human immunodeficiency virus (HIV), hepatitis B or C at the Screening Visit
• Confirmed to have severe damage to the vaginal epithelium in the physical examination at the Screening Visit

Sponsors & Collaborators

• AtoGen Co. Ltd: lead
• ATOGEN AUSTRALIA PTY LTD: collaborator

Study Sites (1)

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Related Publications (7)

• 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.

  PMID: 23912864 BACKGROUND

• 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.

  PMID: 23659989 BACKGROUND

• 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.

  PMID: 34292926 BACKGROUND

• 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.

  PMID: 25291116 BACKGROUND

• 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.

  PMID: 25305660 BACKGROUND

• 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.

  PMID: 22721635 BACKGROUND

• 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.

  PMID: 22777592 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginal Diseases; Bacterial Infections; Vaginitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Christopher Argent, Dr.

  Scientia Clinical Research Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scientia Clinical Research Study Team

CONTACT

+61 02 9382 5800; christopher.argent@scientiaclinicalresearch.com.au

AtoGen Assistant Manager

CONTACT

+82 70 7725 2203; skim@atogen.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eight participants will be randomized to be allocated into either a treatment group or a placebo control group (3:1 ratio) for each cohort. There will be three ascending dose cohorts. For the first two doses, the next dose cohorts will begin enrollment only after the safety data review meets a satisfactory evaluation by the safety review committee.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: November 2, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)