A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
Completed · Phase 1 · Has a placebo group
Conditions studied: Chronic Hepatitis B
In brief
This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
Key facts
- Study ID
- NCT03714152
- Run by
- Assembly Biosciences
- People needed
- 80
- Starts
- 2018-11-13
- Expected to finish
- 2021-01-07
- Last updated by the study team
- 2021-01-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Southern California Research Center — Coronado, California, United States
- Research and Education — San Diego, California, United States
- Quest Clinical Research — San Francisco, California, United States
- Infectious Disease Care — Hillsborough, New Jersey, United States
- Monash University — Clayton, Victoria, Australia
- The Alfred Hospital — Melbourne, Victoria, Australia
- Linear Clinical Research — Nedlands, Western Australia, Australia
- First Hospital of Jilin University — Jilin City, Changchun, China
- University of Hong Kong, Queen Mary Hospital — Hong Kong, Hong Kong
- Auckland Clinical Studies — Auckland, New Zealand
- Hallym University — Chuncheon, South Korea
- Asan Medical Center — Seoul, South Korea
- Severance Hospital, Yonsei University — Seoul, South Korea
- King's College London — London, United Kingdom
Full record on ClinicalTrials.gov
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