A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers
It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir Fumarate Tablets in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
69
Oral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD).
Placebo to match Hepenofovir Fumarate Tablets
Oral Tabet; Subjects will receive Hepenofovir Fumarate Tablets Dose4 on Day 1 in fast condition, then receive Hepenofovir Fumarate Tablets Dose4 on Day 8 in fed condition.
Safety measured by adverse events
Time frame: Up to 6 Days in SAD Cohorts
Safety measured by adverse events
Time frame: Up to 12 Days in MAD Group
Safety measured by adverse events
Time frame: Up to 13 Days in Food-influence Group
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.