A Phase 1 interventional study of ABI-H2158 and Placebo for ABI-H2158 in Chronic Hepatitis B, sponsored by Assembly Biosciences. Completed at 14 sites in 7 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Assembly Biosciences · Phase 1, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Assembly Biosciences is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers:
Chronic HBV patients:
Key Inclusion Criteria:
In good general health except for chronic HBV infection, documented by:
Key Exclusion Criteria:
ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days
Drug: ABI-H2158
Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days
Drug: Placebo for ABI-H2158
5 mg or 25 mg tablets
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Up to 28 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Assembly Biosciences