Healthy Volunteers Clinical Trial
Official title:
A Two-part, Randomized, Double-blind, Placebo-controlled, First-In-Human, Phase I Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 Following Administration of Single and Multiple Ascending Oral Doses in Healthy Volunteers
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) following single and multiple ascending dose administration of SPR720 administered orally in healthy volunteers.
This is a single-center, phase I, randomized, double-blind, placebo-controlled, first-in-man
study. Up to 120 healthy volunteers may be enrolled in this 2-part, multi-cohort study. In
both Part 1 and Part 2, sequential cohorts will be exposed to increasing doses of SPR720.
Each cohort will enrol 8 subjects, randomized (3:1) to receive SPR720 (6 subjects) or placebo
(2 subjects). Each subject will be assigned to only one cohort.
In Part 1 single ascending dose (SAD):
A single oral dose of SPR720 (n=6) or placebo (n=2) will be administered to 8 subjects at an
initial dose level of 100 mg. Additional cohorts of 8 subjects will be enrolled to
investigate increasing doses of SPR720 ranging from 250 mg to 3000 mg. All subjects will
receive SPR720 (or placebo) by oral administration in the fasted state. One Part 1 cohort
(the Food Effect Cohort) will receive an additional single dose of SPR720 (or placebo) in the
fed state.
Part 2 multiple ascending dose (MAD):
SPR720 (or placebo) will be administered to approximately 3 planned dose cohorts of 8
subjects each. Subjects will receive SPR720 (or placebo) orally once daily for 7 (or 14)
consecutive days starting with a planned initial dose of 500 mg. Additional cohorts of 8
subjects will be enrolled to investigate repeated daily doses of SPR720 ranging from 1000 mg
to 1500 mg.
For both Part 1 and Part 2, a Safety Monitoring Group (SMG) will review cumulative safety and
PK data from each cohort before proceeding to the next cohort/dose level. Doses to be
evaluated in each subsequent cohort may be modified by the SMG based on review of safety and
PK data from preceding cohorts. Part 2 will run concurrent with Part 1 and will be initiated
following SMG review of safety and PK data for the corresponding Part 1 dose level cohort.
Part 1 will be conducted in up to 64 subjects (8 planned dose cohorts of 8 subjects each).
Part 2 will be conducted in up to 24 subjects (3 planned dose cohorts of 8 subjects each);
additional cohorts of 8 subjects each (up to 16 additional subjects) may be enrolled in
either Part if further investigation of SPR720 is required.
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