Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of EDP-721 in combination with EDP-514 in patients with chronic hepatitis B virus infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
Oral administration (Part 1)
Placebo to match EDP-721, oral administration (Part 1)
Oral administration (Part 2)
New Zealand Clinical Research Ltd
Auckland, New Zealand
Safety measured by adverse events
Time frame: Up to 8 Days in HV SAD Cohorts
Safety measured by adverse events
Time frame: Up to 21 Days in HV MAD Cohorts
Safety measured by adverse events
Time frame: Up to 70 Days in NUC-suppressed CHB MAD Cohorts
Safety measured by adverse events
Time frame: Up to 98 Days in Viremic CHB MAD Cohorts
Cmax of EDP-721
Time frame: Up to 6 Days in HV SAD Cohorts
AUC of EDP-721
Time frame: Up to 6 Days in HV SAD Cohorts
Cmax of EDP-721
Time frame: Up to 18 Days in HV MAD Cohorts
AUC of EDP-721
Time frame: Up to 18 Days in HV MAD Cohorts
Cmax of EDP-721 alone and in combination with EDP-514
Time frame: Up to 28 Days in All CHB MAD Cohorts
AUC of EDP-721 alone and in combination with EDP-514
Time frame: Up to 28 Days in All CHB MAD Cohorts
Cmax of EDP-514 in combination with EDP-721
Time frame: Up to 28 Days in All CHB MAD Cohorts
AUC of EDP-514 in combination with EDP-721
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo to match EDP-721 (Part 2)
Oral administration
Placebo to match EDP-514
Time frame: Up to 28 Days in All CHB MAD Cohorts
Change from baseline in HBV DNA Viral Load Assay
Time frame: Through Day 28 in All CHB MAD Cohorts
Change from baseline in quantitative HBsAg
Time frame: Through Day 28 in All CHB MAD Cohorts