A randomized study of ALG-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in CHB subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
single or multiple doses of ALG-125755
single or multiple doses of placebo
MBAL Sveta Sofia EOOD, Dept of Internal Medicine with Gastroenterology Section
Sofia, Bulgaria
PMSI Republican Clinical Hospital "t. Mosneaga", ARENSIA Exploratory Medicine Phase 1 Unit
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand
National Institute for Infection Diseases, ARENSIA Exploratory Medicine S.R.L.
Bucharest, Romania
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of various doses of ALG-125755 in HV subjects and CHB subjects
Time frame: Up to 32 days for Part 1
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 52 days for Part 2
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 616 days for Part 3
Maximum plasma concentration (Cmax)
Pharmacokinetic parameters of ALG-125755 in plasma
Time frame: Predose (0 hours) up to 616 days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-125755 in plasma
Time frame: Predose (0 hours) up to 616 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-125755 in plasma
Time frame: Predose (0 hours) up to 616 days
Antiviral activity of ALG-125755 as measured by quantitative changes in serum
Pharmacokinetic parameters of ALG-125755 in plasma
Time frame: Predose (0 hours) up to 616 days
Minimum plasma concentration (Cmin)
Pharmacokinetic parameters of ALG-125755 in plasma
Time frame: Predose (0 hours) up to 616 days
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Change in HBsAg from baseline through up to 112 days from last dose in multiple dose HBV infected subjects
Time frame: screening to up to 112 days