This is a Phase 1, double-blind, placebo-controlled trial in three parts. A single ascending
dose (SAD) study in six cohorts receiving a single subcutaneous (SC) dose of 1, 10, 30, 60,
100, or 200 mg of rezafungin; a multiple ascending dose (MAD) study in four cohorts receiving
30 mg x 3 doses, 60 mg x 3 doses, 100 mg x 3 doses, or 200 mg x 3 doses of rezafungin SC with
dosing frequency of once every 7 days; and a two-period cross-over bioavailability (BA) study
receiving 100 mg of rezafungin. The two period cross-over BA study will be assessed unblinded
in two sequences (10 subjects, 100 mg or maximum tolerated dose (MTD) of rezafungin in Part
1); 5 subjects will receive an SC injection of rezafungin in Period 1 followed by an
intravenous (IV) infusion of rezafungin in Period 2, and 5 subjects will receive an IV
infusion of rezafungin in Period 1 followed by an SC injection of rezafungin in Period 2.
Each SAD (except cohort 1) and MAD cohort will contain 8 subjects (6 subjects will receive a
SC injection of rezafungin and 2 subjects will receive placebo). Each SAD (except cohort 1)
and MAD cohort will be conducted with sentinel dosing. SAD cohort 1 will be comprised of 4
subjects (3:1 rezafungin to placebo) with no sentinel dosing. Parts 2 and 3 of the study will
only be conducted after FDA review for safety data and PK data from all subjects
participating in Part 1; Part 3 may be run in parallel with the first cohort (Cohort 7) of
Part 2. Individuals in the SAD cohorts will participate for approximately 58 days, including
up to 28 days for screening and 30 days for dosing and follow-up (FU). Individuals in the MAD
cohorts will participate for approximately 73 days, including up to 28 days for screening and
45 days for dosing and FU. Individuals in the BA cohorts will participate for approximately
80 days, including up to 28 days for screening and 52 days for dosing and FU. The study will
have a duration of approximately 30 months. The primary objectives are to determine the: 1)
safety and tolerability of single ascending SC doses (SAD) of rezafungin; 2) safety and
tolerability of multiple ascending SC doses (MAD) of rezafungin; and 3) pharmacokinetic (PK)
profile in plasma of rezafungin in healthy adult subjects.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)