A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
- Registration Number
- NCT04485663
- Lead Sponsor
- Aligos Therapeutics
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALG-010133 ALG-010133 Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks Placebo Placebo Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] up to 162 days for Part 3 The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
- Secondary Outcome Measures
Name Time Method Half-time [t1/2] Predose (0 hours) up to 162 Days (3864 hours) Pharmacokinetic parameters of ALG-010133 in plasma
Area under the concentration time curve [AUC] Predose (0 hours) up to 162 Days (3864 hours) Pharmacokinetic parameters of ALG-010133 in plasma
Minimum Plasma Concentration [Cmin] Predose (0 hours) up to 162 Days (3864 hours) Pharmacokinetic parameters of ALG-010133 in plasma
Maximum Plasma Concentration [Cmax] Predose (0 hours) up to 162 Days (3864 hours) Pharmacokinetic parameters of ALG-010133 in plasma
Time to maximum plasma concentration [Tmax] Predose (0 hours) up to 162 Days (3864 hours) Pharmacokinetic parameters of ALG-010133 in plasma
Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78
Trial Locations
- Locations (10)
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit
🇲🇩Chisinau, Moldova, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
King's College Hospital
🇬🇧London, United Kingdom
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
ACS
🇳🇿Auckland, New Zealand
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong