drugset / Trial / NCT07439263
Single Ascending Dose Study of HB2198 in Healthy Participants
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-03-19
- Primary completion
- 2026-08-14
- Completion
- 2026-08-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HB2198 | Unknown | 0.001 mg/kg | Intravenous |
| Comparator | HB2198 | Unknown | 0.1 mg/kg | Intravenous |
Indications
No indication recorded.