This was a single-center, phase I, randomized, double-blind, placebo-controlled, first-in-man study. 96 healthy volunteers were enrolled in this 2-part, multi-cohort study. In both Part 1 and Part 2, sequential cohorts were exposed to increasing doses of SPR720. A total of 96 healthy volunteers (n = 8/cohort, 3:1 randomization) received SPR720 (or placebo) as single oral doses ranging from 100 to 2,000 mg or repeat total daily doses ranging from 500 to 1,500 mg for 7 or 14 days. SPR720 was well tolerated at daily doses of up to 1,000 mg for up to 14 days. The results of this first-in-human study suggest that predicted therapeutic exposures of SPR719 can be attained with a once-daily oral administration of SPR720.
Trial
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
Overview
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