EICHORCondition: Healthy Volunteer · Sponsor: Hinge Bio
Interested? Contact the study team ↓
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.
This description comes directly from the study's public registry record.
Joshua Pelham · 1-415-378-4738 · joshua.pelham@hingebio.com
Kristen Quigley · kristen.quigley@hingebio.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Veritus Research | Bayswater, Victoria, Australia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07439263