A Phase 1 interventional study of HH-003 injection and Placebo in Chronic HBV Infection, sponsored by Huahui Health. Completed at 11 sites in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Huahui Health · Phase 1, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the safety, tolerability and pharmacokinetics of HH-003 injection in treatment-naive participants chronically infected with hepatitis B virus.
Huahui Health is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Drug: HH-003 injection
Drug: Placebo
HH-003 injection is administrated via I.V. infusion
Placebo is administrated via I.V. infusion
Incidence of Treatment-Emergent Adverse Events
Time frame: From the first dose of study drug until Day 57
Peak concentration (Cmax)
Time frame: From predose to Day 113
Area under the drug-time curve (AUC0-2W)
Time frame: From predose to Day 113
Area under the drug-time curve (AUClast)
Time frame: From predose to Day 113
Area under the drug-time curve (AUCinf)
Time frame: From predose to Day 113
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Libevitug