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Recruiting NCT07439263

Single Ascending Dose Study of HB2198 in Healthy Participants

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains, Placebo comparator: HB2198 Diluent.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: up to 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

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

Primary outcome measures

  • Safety and Tolerability [Time frame: Time Frame: Day 1 to Day 28; may extend to Month 2]
  • Dose Limiting Toxicities (DLTs) [Time frame: Day 1 through Day 28]
Secondary outcome measures (6)
  • To characterize the pharmacokinetic (PK) profile of HB2198 [Time frame: Day 1 to Month 2]
  • To characterize the pharmacokinetic (PK) profile of HB2198 [Time frame: Day 1 to Month 2]
  • To characterize the pharmacokinetic (PK) profile of HB2198 [Time frame: Day 1 to Month 2]
  • To characterize the pharmacokinetic (PK) profile of HB2198: [Time frame: Day 1 to Month 2]
  • To evaluate the development of anti-drug antibodies (ADAs) [Time frame: Day 1 to Month 2]
  • To evaluate B-cell depletion and other pharmacodynamic changes [Time frame: Day 1 to Month 2]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Veritus Research — Bayswater

Identifiers

NCT: NCT07439263 · HB2198-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗