A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus

NCT04767321 | Completed Phase 1

• 1 other identifier: C20-109-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the safety, tolerability, exploratory efficacy and exposure of LTX-109 administered topically to the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible S. aureus \[MSSA\] and/or methicillin-resistant S. aureus \[MRSA\]).

Conditions

Nasal Decolonization of Staphylococcus Aureus

Outcome Measures

Primary Outcomes (10)

• Assessment of safety by occurence and frequency of Adverse Events

  Occurrence and frequency of Adverse Events

  Through treatment and followup of 22 days

• Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point graded scale.

  Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)

  Day 1

• Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point graded scale.

  Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)

  Day 2

• Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.

  Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)

  Day 3

• Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.

  Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)

  Day 4

• Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.

  Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)

  Day 8

• Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.

  Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)

  Day 15

• Local tolerability assessed by a qualified health care professional by evaluation of nostrils and scoring using a 4-point scale.

  Incidence of local reactions (erythema, swelling and lesions) will be assessed by a qualified health care professional . Each nostril will be evaluated separately and scored using a 4-graded scale (0-3)

  Day 22

• Local tolerability assessed by the subject by Visual Analog Scale.

  Assessment of Local tolerability on Visual Analog Scale

  Day 1

• Local tolerability assessed by the subject by Visual Analog Scale.

  Assessment of Local tolerability on Visual Analog Scale

  Day 2

Secondary Outcomes (5)

• Number of subjects on LTX-109 versus placebo with bacterial eradication at Test of Cure

  54 hours (+ 2 hours)

• Number of subjects on LTX-109 versus placebo with bacterial eradication at other specified time points than Time of Cure.

  4, 6, 12, 24, 78 hours and Days 8, 15 and 22

• Number of colony forming units (CFUs) in subjects on LTX-109 versus placebo at specified points in time.

  4, 6, 12, 24, 78 hours and Days 8, 15 and 22

• Number of subjects on LTX-109 vs placebo with bacterial recolonisation defined as the timepoint of recurrence of colonisation after confirmed eradication.

  Days 4, 8, 15 and 22

• Plasma concentrations of LTX-109

  6, 24, 54 and 78 hours

Study Arms (2)

LTX-109 treatment

EXPERIMENTAL

Nasal application of LTX-109 gel 3% (w/w), 250 mikroliters in each nostril, 4 times in one day, every two hours.

Drug: LTX-109 gel, 3% w/w

Placebo

EXPERIMENTAL

Nasal application of placebo, 250 mikroliters in each nostril, 4 times in one day, every two hours.

Drug: Placebo

Interventions

LTX-109 gel, 3% w/w DRUG

LTX-109 gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.

LTX-109 treatment

Placebo DRUG

Placebo gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Male or female subject aged 18 to 65 years inclusive at Visit 2.
• Persistent nasal carrier of Staphylococcus aureus (MSSA and/or MRSA), confirmed by two positive bacterial cultures from the nose during the screening period.
• Clinically normal medical history, physical findings, vital signs and laboratory values at the time of screening Visit 2, as judged by the Investigator.
• Women of child bearing potential (WOCBP) must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of \< 1% to prevent pregnancy (combined \[oestrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\]or intrauterine hormone-releasing system \[IUS\]) from at least 2 weeks prior to dose to 2 weeks after last dose. Female subjects must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.
• Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone \[FSH\] 25-140 IE/L is confirmatory).
• Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of \< 1% to prevent pregnancy (see above).

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• Severe eczema or skin wounds, dry or sensitive skin assessed as clinically significant by the Investigator.
• Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
• Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to LTX-109 or chlorhexidine.
• S. aureus (MSSA and/or MRSA) decolonisation attempt in the 6 months prior to screening Visit 2.
• Inability to take medications nasally.
• Nasal polyps or significant anatomical nasal abnormality, as judged by the Investigator.
• Evidence of open wound, lesion, inflammation, erythema or infection (including active rhinitis, sinusitis or upper respiratory infection) affecting the nostril area, lip and skin close to the nose.
• History of multiple episodes (\>3) of epistaxis within 12 months prior to screening Visit 2.
• Disease in the region of the application sites, significant history of trauma or skin disease in the region of the application sites, current nasal skin or nasal septum condition requiring treatment or nasal surgery in the 6 months prior to screening Visit 2.
• In situ nasal jewellery or open nasal piercings.
• Previous or concurrent treatment with antimicrobials for an infection within the last 30 days prior to the first administration of IMP.
• Regular use of cortisone or anticoagulation medication within 14 days prior to the first administration of IMP and regular use of nasal decongestants within 30 days prior to the first IMP administration, at the discretion of the Investigator.

Sponsors & Collaborators

• Pharma Holdings AS: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

ClinSmart Sweden AB

Uppsala, SE-752 37, Sweden

Location

Study Officials

• Johan Nilsson, MD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomised, Double-blind, Placebo-controlled Randomization 3:1, active to placebo

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 23, 2021
• Study Start: February 22, 2021
• Primary Completion: March 23, 2021
• Study Completion: June 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)