Single ascending dose of HB2198 in healthy adults
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
Run by Hinge Bio · NCT07439263 · Data updated 2026-11-12
This will test a single IV dose of HB2198 to see if it is safe and how it acts in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 55 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Hinge Bio Industry-sponsored |
| Locations | 1 site (Bayswater, Victoria) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | August 14, 2026 |
| Study ends | August 21, 2026 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07439263 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–55 with peripheral B-cell counts in the normal range, IgG ≥600 mg/dL, not pregnant, and able to comply with confinement and follow-up are ideal candidates.
✕Probably not a fit
People with active infections, immunodeficiency, positive HIV/HBV/HCV tests, pregnancy, or those seeking therapeutic benefit for an existing B-cell disease are unlikely to receive clinical benefit from this healthy-volunteer study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled single ascending dose study in healthy adults. Four dose levels will be explored with sentinel dosing (one active and one placebo) before dosing the remaining participants in each 8-person cohort. Approximately 32 participants (6 active:2 placebo per cohort) will receive a single IV infusion and be followed for safety, pharmacokinetics, pharmacodynamics, and immunogenicity through Day 28 and to Month 2, with extended follow-up if B-cell counts remain suppressed. Key measurements include B-cell depletion kinetics, lymphocyte phenotyping, cytokines, quantitative immunoglobulins, and anti-drug antibodies.
Why it matters
Potential benefit: If HB2198 proves safe and active, it could lead to a new antibody therapy that more effectively targets B cells in conditions such as certain blood cancers or autoimmune diseases.
How similar studies have gone: Monospecific anti-CD19 and anti-CD20 antibodies have established efficacy, but tetravalent bispecific antibodies with dual Fc engineering are a newer approach with limited clinical outcome data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-55 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 Criteria: * 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
Where it's running
-
Veritus Research
Bayswater, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Joshua Pelham
- Email: joshua.pelham@hingebio.com
- Phone: 1-415-378-4738
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.