Clinical Trial

Single Ascending Dose Study of HB2198 in Healthy Participants

Recruiting Phase 1
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Record status
This record was last updated April 13, 2026 (before its estimated August 14, 2026 completion). Its status may not reflect the trial's current state.
Summary
Phase 1, single center, randomized, double blind, placebo controlled SAD study assessing safety, tolerability, PK, PD, and immunogenicity of HB2198 after a single IV infusion in healthy adults. Four dose levels will be explored with sentinel participants per cohort. Approximately 32 participants (6 HB2198:2 placebo per cohort) will be followed for \~2 months, with extended follow up if B-cell counts remain suppressed.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-14
Trial Details
NCT Number NCT07439263
Lead Sponsor Hinge Bio
Conditions Healthy Volunteer
Enrollment 32 participants
Start Date 2026-03-19
Primary Completion 2026-08-14 (estimated)
Study Completion 2026-08-21 (estimated)
Updated on ClinicalTrials.gov 2026-04-13