Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug (AWOL)
Filariasis, Lymphatic, Onchocerciasis
About this trial
This is an interventional treatment trial for Filariasis, Lymphatic focused on measuring Lymphatic filariasis, Onchocerciasis, Wolbachia, Phase 1, Healthy volunteers, Randomized, Double blind, Placebo
Eligibility Criteria
Inclusion Criteria:
1. Healthy male and female participants 2 aged 18-65 years 3 BMI 18.0-35.0 kg/m2, maximum weight 100 kg 4 in good health, as determined by: 4a medical history, 4b physical examination, 4c vital signs assessment, 4d 12-lead ECG 4e clinical laboratory evaluations 5 provision of informed consent and abide by study restrictions
Exclusion Criteria:
- not willing to abide by contraception restrictions
- donated blood in previous 3 months, plasma previous 7 days, platelets previous 6 weeks
- consumption >14 units of alcohol/week
- tobacco smoking
- concomitant medication, apart from treatments for mild asthma, eczema, contraception, paracetamol
- herbal remedies
- history of anaphylaxis, drug allergy, clinically significant atopic condition as determined by Investigator
- clinically significant medical history, as determined by the Investigator
- positive hepatitis, HIV serology
- live vaccine in previous 3 months, Covid-19 vaccine prior 14 days
- Participants who, in the opinion of the Investigator, should not participate in this study.
Sites / Locations
- Liverpool University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
AWZ1066S
Placebo
AWZ1066S Part A Cohort A1- 100mg single dose Cohort A2- 200mg single dose Cohort A3- 400mg single dose Cohort A4- 800mg fasted single dose and 800mg fed single dose Cohort A5- 1200mg single dose Cohort A6- 1600mg single dose The doses for part B will be selected following review of data from Part A. Cohort B1- AWZ1066S once daily for 7 days Cohort B2- AWZ1066S once daily for 7 days Cohort B3- AWZ1066S once daily for 7 days Cohort B4- AWZ1066S once daily for 7 days
Placebo Cohort A1- equivalent placebo single dose Cohort A2- equivalent placebo single dose Cohort A3- equivalent placebo single dose Cohort A4- equivalent placebo fasted single dose and equivalent placebo fed single dose Cohort A5- equivalent placebo single dose Cohort A6- equivalent placebo single dose The doses for part B will be selected following review of data from Part A. Cohort B1- equivalent placebo once daily for 7 days Cohort B2- equivalent placebo once daily for 7 days Cohort B3- equivalent placebo once daily for 7 days Cohort B4- equivalent placebo once daily for 7 days