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Single Ascending Dose Study of HB2198 in Healthy Participants

NCT07439263 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains

Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1.

DRUG

Placebo comparator: HB2198 Diluent

HB2198 Diluent: single IV infusion

Sponsors & Collaborators

  • Hinge Bio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2026-08-14
Completion
2026-08-21

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07439263 on ClinicalTrials.gov