Relative Bioavailability of LY03010 Compared to Listed Drug
Status:
Recruiting
Trial end date:
2022-01-10
Target enrollment:
Participant gender:
Summary
This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo
screening evaluations to determine eligibility within 28 days prior to study drug
administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1
of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before
dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will
stay at site till Day 2 after PK collection. All subjects will return to the clinical sites
at designated study days for dosing, PK sample collections and assigned clinical activities.
All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg
LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing
of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects
randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM
injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in
the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the
gluteal muscle with the last dose on Day 148.
End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last
dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last
dosing. At EOS visit, subjects will complete the study after a series of assigned clinical
assessments. A 30-day follow up call will be conducted by the clinical research staff to
ensure participant's well-being.