Single Ascending Dose Study of HB2198 in Healthy Participants

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT07439263

Run by

Hinge Bio

People needed

32

Starts

2026-03-19

Expected to finish

2026-08-21

Last updated by the study team

2026-04-13

Who can join

Age: any, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Veritus Research — Bayswater, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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