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NCT Number: NCT07439263

Single Ascending Dose Study of HB2198 in Healthy Participants

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.

Recruiting

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Key information

Conditions

Healthy Volunteer

Age range

Up to 55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Veritus Research

Bayswater, Victoria, 3153, Australia

Location status: Recruiting

About this study

HB2198 is a tetravalent bispecific antiCD19/CD20 antibody engineered with dual Fc domains (S239D/I332E) to enhance FcγR engagement. Cohorts (n=8 each) receive a single IV dose of HB2198 or placebo under double blind conditions; 2 sentinels (1 active, 1 placebo) are dosed ≥48 h before the remaining 6 participants. Safety/PK/PD and immunogenicity are characterized through Day 28 and to Month 2, including B-cell depletion kinetics, lymphocyte phenotyping, cytokines, quantitative immunoglobulins, and ADAs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Placebo comparator: HB2198 Diluent

Drug

HB2198 Diluent: single IV infusion

Primary outcomes

  1. Safety and Tolerability

    Time frame: Time Frame: Day 1 to Day 28; may extend to Month 2

    Incidence/severity of AEs and SAEs (CTCAE v5.0)

  2. Dose Limiting Toxicities (DLTs)

    Time frame: Day 1 through Day 28

    DLT's as defined within the protocol.

Secondary outcomes

  1. To characterize the pharmacokinetic (PK) profile of HB2198

    Time frame: Day 1 to Month 2

    Area under the concentration versus time curve (AUC)

  2. To characterize the pharmacokinetic (PK) profile of HB2198

    Time frame: Day 1 to Month 2

    Maximum drug concentration (Cmax)

  3. To characterize the pharmacokinetic (PK) profile of HB2198

    Time frame: Day 1 to Month 2

    Time to maximum plasma concentration (tmax)

  4. To characterize the pharmacokinetic (PK) profile of HB2198:

    Time frame: Day 1 to Month 2

    Area Under the Curve to last measurable concentration (AUClast)

  5. To evaluate the development of anti-drug antibodies (ADAs)

    Time frame: Day 1 to Month 2

    ADA incidence

  6. To evaluate B-cell depletion and other pharmacodynamic changes

    Time frame: Day 1 to Month 2

    B-cell depletion and subsets; duration; change in total immunoglobulins; cytokines/CRP and other biomarkers.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Pelham

CONTACT

[email protected]

1-415-378-4738

Kristen Quigley

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hinge Bio

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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