Efficacy and Safety Study of Moxidectin in Adults With Scabies

Inclusion Criteria:

1. Aged 18 years or older.

2. Provided written informed consent.

3. Diagnosis of active scabies infestation confirmed by the presence of clinical signsand symptoms (evidence of burrows or typical inflammatory/noninflammatory lesionsand pruritus) and either microscopic confirmation of scabies mite(s), ova or scybalaby skin scraping or dermoscopy.

4. All female subjects of childbearing potential must agree to the use of a highlyeffective method of birth control until 16 weeks after administration ofInvestigational Product (IP).

Exclusion Criteria:

1. Diagnosis of crusted/Norwegian scabies or scabies presentation that, in the opinionof the Investigator, would require treatment with more than one standard of caretreatment for scabies (e.g., scabies requiring concurrent topical and oraltreatment).

2. History of chronic or recurrent dermatologic disease or skin conditions other thanscabies that could interfere with the diagnosis of scabies and evaluation of cure.

3. Received any treatment with one or more scabicides within the 28 days prior toScreening, or between Screening and Baseline, including but not limited topermethrin, ivermectin, benzyl benzoate, sulfur, lindane, crotamiton, malathion, teatree oil or spinosad.

4. Body mass index > 35 kg/m2.

5. Creatinine clearance < 30 mL/min (using Cockcroft-Gault equation).

6. Both total bilirubin >1.5 x upper limit of normal (ULN) and AST > ULN.

7. Abnormal and clinically relevant findings in hematology or biochemistry assessmentsat Screening, or in vital signs, 12-lead ECG, or physical examination at Screeningand/or Baseline, that in the opinion of the Investigator would put the subjects atincreased risk from participating in the study, confound study evaluations, or mayinterfere with study conduct.

8. Presence of any other clinically relevant condition, including infection,immunological disorder, malignant disease, and/or other underlying condition orcircumstance at Screening or Baseline that in the opinion of the Investigator wouldput the subjects at increased risk from participating in the study, confound studyevaluations, or interfere with the study conduct.

9. Use of topical steroids, systemic or high-dose inhaled corticosteroids (>500 µg perday of fluticasone propionate or equivalent for adults), or other immunomodulatorswithin 14 days of Baseline.

10. Requiring ongoing treatment with, or received within 5 half-lives before Screening,any of the following medications that are clinical BCRP inhibitors: curcurmin (turmeric) supplements, cyclosporine A, darolutamide, eltrombopag, febuxostat,fostamatinib, rolapitant and teriflunomide.

11. Received an investigational agent within 28 days of Screening (or 5 half-lives ofthe investigational agent, whichever is longer).

12. Known or suspected hypersensitivity to macrocyclic lactones or excipients used inthe formulation of moxidectin or ivermectin.

13. Known or suspected hypersensitivity to any of the components in permethrin 5% cream,to any synthetic pyrethroid or pyrethrin, or to the components of spinosad 0.9%topical suspension.

14. Known, suspected or at risk of Loa loa coinfection.

15. Difficulty swallowing tablets or capsules.

16. Pregnant or breastfeeding or planning to become pregnant from Screening until 16weeks after treatment with IP.

17. Known or suspected alcohol or illicit substance abuse.

18. Unwilling, unlikely or unable to comply with all protocol specified assessments.

19. Previous enrolment in this study.

20. Previous moxidectin exposure within 6 months (5 half-lives) from Baseline.

21. Has household members who refuse or are unable to receive permethrin 5% creamtreatment for scabies.