NCT07439263

Single Ascending Dose Study of HB2198 in Healthy Participants

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Hinge Bio · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

HB2198 is a tetravalent bispecific antiCD19/CD20 antibody engineered with dual Fc domains (S239D/I332E) to enhance FcγR engagement. Cohorts (n=8 each) receive a single IV dose of HB2198 or placebo under double blind conditions; 2 sentinels (1 active, 1 placebo) are dosed ≥48 h before the remaining 6 participants. Safety/PK/PD and immunogenicity are characterized through Day 28 and to Month 2, including B-cell depletion kinetics, lymphocyte phenotyping, cytokines, quantitative immunoglobulins, and ADAs.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo comparator: HB2198 Diluent	HB2198 Diluent: single IV infusion

Timeline

• Start date: 2026-03-19
• Primary completion: 2026-08-14
• Completion: 2026-08-21
• First posted: 2026-02-27
• Last updated: 2026-04-13

Locations

1 site across 1 country: Australia