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
Hinge Bio
32 participants
Mar 19, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- -55 years; Healthy Adults
- IgG ≥ 600 mg/dL
- Peripheral B cell count within lab normal range
- Negative pregnancy test (WOCBP) and protocol specified contraception
- Confinement from Day -1 through ≥24 h after Day 1 dosing
- Informed consent
Exclusion Criteria8
- Clinically significant disease that could affect safety or data
- Hypogammaglobulinemia; active/recent significant infection
- Chronic antivirals/antimicrobials
- Recent major surgery; live vaccine <30 days (inactivated ≥14 days before Day 1 recommended)
- Positive TB screen without treatment
- HBV DNA+ or HCV RNA+; HIV+
- Pregnancy/breastfeeding
- Planned conception or gamete donation within 6 months post dose
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Interventions
Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1.
HB2198 Diluent: single IV infusion
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07439263