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This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of three sub-parts which will be used to further refine the dose and dosing regimen, and to evaluate the safety and efficacy of RO7062931 when administered with standard-of-care (SoC) therapy.
Enrollment
Sex
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Volunteers
Inclusion criteria
FOR HEALTHY VOLUNTEERS ONLY - PART 1 -
FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b:
FOR CHB PARTICIPANTS ONLY - PART 2c
Exclusion criteria
FOR HEALTHY VOLUNTEERS ONLY - PART 1:
FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b:
FOR CHB PARTICIPANTS ONLY - PART 2c
Primary purpose
Allocation
Interventional model
Masking
119 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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