None listed
Conditions
Brief summary
This is the first in human study to evaluate the safety and tolerability of topical treatment, HXP124 in otherwise healthy patients with mild to moderate fungal toenails infections, onychomycosis. The study also aims to evaluate the effectiveness of HXP124 in treating onychomycosis.
Interventions
HXP124
Dose:
20ul per application per toe and all toenails on both feet will be applied regardless of how many infected toenails
Part 1 - Multiple ascending dose study, 6 participants (4 active, 2 placebo) per cohort
Cohort 1: 5mg/ml per application
Cohort 2: 10mg/ml per application
Cohort 3: 20mg/ml per application
Part2: single dose study, 30 participants (24 active, 6 placebo)
Cohort 4: dose level to be determined from Part 1.
Duration:
once daily for 42 days
Mode of administration:
Top
HXP124 Dose: 20ul per application per toe and all toenails on both feet will be applied regardless of how many infected toenails Part 1 - Multiple ascending dose study, 6 participants (4 active, 2 placebo) per cohort Cohort 1: 5mg/ml per application Cohort 2: 10mg/ml per application Cohort 3: 20mg/ml per application Part2: single dose study, 30 participants (24 active, 6 placebo) Cohort 4: dose level to be determined from Part 1. Duration: once daily for 42 days Mode of administration: Topical by brush Method of monitor adherence: Follow up the patients on week 1, 2, 6, 9 and 12, and participants will be given a diary card to record the time of drug application each day. Patients will also receive text messages on their phones daily as reminders to apply drug every day and their clinic appointments. Duration of treatment: 42 days Follow up duration: Part 1: 12 weeks Part2: 52 weeks
Sponsors
Hexima Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmation of onychomycosis by mycological staining and/or culture from affected great toenail(s). 2. Appearance of onychomycosis involving at least 20% but not more than 70% of one (or both) affected Great toenail(s) as determined by visual inspection after the nail has been trimmed. 2. The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is < 3 mm. 3. Adult male and females, 18 to 65 years of age (inclusive) at the time of screening. 4. Medically healthy with clinically insignificant screening results (e.g. laboratory profiles, medical history, ECGs, physical exam), as judged by the PI. 5. Negative urine drug screen/alcohol breath test at screening and Day 1. 6. Voluntary consent to participate in the study. 7. Body Mass Index (BMI) between 17.5 and 35 inclusive. 8. Participants must be instructed to use a highly effective, double barrier contraception (both male and female partners) during the study and for 1 month (females) and 3 months (males) following the final dose of HXP124. Double barrier contraception is defined as a condom AND one other form of the following: a. Birth control pills (The Pill) b. Depot or injectable birth control c. IUD (Intrauterine Device) d. Birth Control Patch (e.g., Ortho Evra) e. NuvaRing® OR f. Surgical sterilisation at least 6 months prior to screening visit. i.e., tubal ligation or hysterectomy for women or vasectomy for men. 9. Males must not donate sperm for at least 3 months post-dose of the last study treatment. Male partners of female participants and female partners of male participants must also use contraception, if they are of childbearing potential. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level > 40 mIU/mL. Rhythm methods will not be considered as highly effective methods of birth control. Participant abstinence for the duration of the study and for 1 month (females) and 3 months (males) after the last dose of HXP124 is acceptable.
Exclusion criteria
1. History of allergy to any of the excipients in HXP124. 2. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV). 3. Have any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the study. 4. Females who are pregnant or lactating. 5. Unwilling to refrain from the use of nail cosmetics such as clear and/or coloured nail lacquers from the screening visit until the end of the study. 6. Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration. 7. Failure to satisfy the principal investigator (PI) of fitness to participate for any other reason. 8. Clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardise his/her safety. 9. Diabetes mellitus requiring treatment other than diet and exercise. 10. Has not undergone the specified washout period(s) for the following topical preparations or if the participant requires the concurrent use of any of the following topical medications: a. Topical antifungal applied to the feet (does not include antifungals for treatment of Tinea pedis during the study: 4 weeks) b. Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks 11. Has not undergone the specified washout period(s) for the following systemic medications or the subject requires the concurrent use of any of the following systemic medications: a. Corticosteroids (including intramuscular injections): 2 weeks b. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 12 weeks 12. Use of systemic immunomodulators in the past 4 weeks. 13. Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated.
Outcome results
None listed