Dose-finding Study of Moxidectin for Treatment of Scabies
Condition: Scabies
MeSH terms: Scabies
Intervention: Moxidectin Oral Product
Intervention description: The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required
Intervention MeSH terms: Moxidectin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel, double blind, multicenter, randomized, pharmacokinetic/pharmacodynamic study. Three cohorts of six subjects per cohort are planned. Subjects will be randomized 1:1:1 to receive 2, 8 or 20 mg moxidectin as a single oral dose. An additional cohort of 36 mg may be initiated with a target sample size of 6 subjects.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: To maintain blinding to treatment allocation, all subjects will receive treatment with the same number of tablets, comprised of moxidectin 2 mg tablets and matched placebo (as required).
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: moxidectin; acaricide; oral

Summary:

      The effective dose of moxidectin to treat human scabies is not known. This study aims to
      provide proof of concept that a single dose of moxidectin is effective in eliminating the
      scabies parasite in humans and to enable the determination of an optimal dose of moxidectin
      for treatment of scabies for further clinical studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged ≥ 18 years.

          2. Provision of written informed consent.

          3. Parasitologically confirmed active Sarcoptes scabiei infestation, defined as the
             presence of at least two lesions (which may include burrows), each containing at least
             one live (internal and/or external structures discernable) adult Sarcoptes scabiei
             mite observed by reflectance confocal microscopy.

          4. Agree to the use of reliable contraceptive measures if female or male partner of a
             female of child-bearing potential from Screening and until 6 months after treatment
             with study product.

        Exclusion Criteria:

          1. History of chronic or recurring dermatologic disease (other than scabies) that could
             interfere with the diagnosis and/or subsequent clinical assessment of scabies.

          2. Diagnosis of crusted/Norwegian scabies or scabies that, in the opinion of the
             Investigator, would require treatment with more than one standard of care (e.g.
             scabies requiring concurrent topical and oral treatment).

          3. Received any treatment for scabies within 7 days of Screening, including but not
             limited to permethrin, ivermectin, benzyl benzoate, lindane, crotamiton, malathion,
             and/or tea tree oil.

          4. Presence of any other clinically relevant condition, including infection,
             immunological disorder, malignant disease, and/or other underlying condition or
             circumstance at Screening or Baseline that would put the subject at increased risk
             from participating in the study or confound study evaluations.

          5. Poor venous access.

          6. Received an investigational agent within 28 days of Screening (or 5 half-lives of the
             investigational agent, whichever is longer).

          7. Body Mass Index over 35 kg/m2.

          8. Clinically relevant abnormal findings in vital signs, 12-lead electrocardiogram (ECG),
             or physical examination at Screening and/or Baseline in the opinion of the
             Investigator.

          9. Clinically relevant laboratory abnormalities at Screening, including:

               1. alanine aminotransferase or aspartate aminotransferase > 2.5 x upper limit of
                  reference range;

               2. creatinine > 2.0 milligrams per deciliter (mg/dL);

               3. hemoglobin < 9.5 g/dL (female) or <10.5 g/dL (male);

               4. amylase > 2.0 x upper limit of reference range.

         10. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the
             formulation of moxidectin.

         11. Use of systemic steroids within 14 days of Screening, or history of prolonged use of
             systemic and/or high-dose inhaled corticosteroids, or use of topical steroids for 7
             out of the 14 days prior to Screening.

         12. Subjects with known or suspected Loa loa coinfection.

         13. Difficulty swallowing tablets.

         14. Pregnant or breastfeeding, or planning to become pregnant.

         15. Known or suspected alcohol or illicit substance abuse.

         16. Unwilling, unlikely or unable to comply with all protocol specified assessments.

         17. Previous enrolment and treatment with moxidectin in this study.