A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
Single or multiple doses of ALG-010133
Single or multiple doses of Placebo
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Hospital of Jilin University
Changchun, Jilin, China
Queen Mary Hospital
Hong Kong, Hong Kong
PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: up to 15 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: up to 29 days for Part 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: up to 162 days for Part 3
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-010133 in plasma
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-010133 in plasma
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-010133 in plasma
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Half-time [t1/2]
Pharmacokinetic parameters of ALG-010133 in plasma
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Minimum Plasma Concentration [Cmin]
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Chisinau, Moldova
ACS
Auckland, New Zealand
Pusan National University Hospital
Busan, South Korea
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
King's College Hospital
London, United Kingdom
Pharmacokinetic parameters of ALG-010133 in plasma
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients
Time frame: Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78