This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study
in healthy adult subjects ages 18 - 45 years inclusive. It is designed to evaluate the safety
and PK of single oral doses of VT-1598. Forty-eight subjects will be enrolled in the study at
1 site in the US and randomized to receive either VT-1598 or placebo in 6 dosage cohorts
(five fasted cohorts and one fed cohort). Each cohort will have 8 subjects; 6 subjects will
receive a single oral dose of VT-1598 and 2 subjects will receive matching placebo. Cohorts 1
- 5 will include 2 sentinel subjects randomized to different treatments. Cohort 6 (receiving
treatment after being fed a high-calorie, high-fat meal) will not include sentinel subjects.
Subjects will be admitted to the study site before dosing and remain at the study site for
safety monitoring and PK assessments for at least 72 hours post-dose. Subjects will return to
the study site on study Days 7, 14, and 21 for outpatient safety monitoring and PK
assessments. There are no formal hypotheses being tested in this Phase 1 trial study. The
primary objectives of this study are 1) to determine the safety of single-ascending oral
doses of VT-1598 in healthy adult subjects in a fasted state, and 2) to determine the safety
of single oral dose of VT-1598 in healthy adult subjects in a fed state.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)