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Single Ascending Dose Study of HB2198 in Healthy Participants
Sponsor: Hinge Bio
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.
Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled Dose Escalating Single Ascending Dose Study of HB2198, a Tetravalent Bispecific Anti CD19/CD20 Antibody With Dual Fc Domains, in Healthy Participants
Key Details
Gender
All
Age Range
Any - 55 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-03-19
Completion Date
2026-08-21
Last Updated
2026-04-13
Healthy Volunteers
Yes
Conditions
Interventions
HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains
Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1.
Placebo comparator: HB2198 Diluent
HB2198 Diluent: single IV infusion
Locations (1)
Veritus Research
Bayswater, Victoria, Australia