Single Ascending Dose Study of HB2198 in Healthy Participants

NCT07439263 | Recruiting Phase 1 DMC

• 1 other identifier: HB2198-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

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

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

• Dose Limiting Toxicities (DLTs)

  DLT's as defined within the protocol.

  Day 1 through Day 28

Secondary Outcomes (6)

• To characterize the pharmacokinetic (PK) profile of HB2198

  Day 1 to Month 2

• To characterize the pharmacokinetic (PK) profile of HB2198

  Day 1 to Month 2

• To characterize the pharmacokinetic (PK) profile of HB2198

  Day 1 to Month 2

• To characterize the pharmacokinetic (PK) profile of HB2198:

  Day 1 to Month 2

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

  Day 1 to Month 2

Study Arms (2)

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

ACTIVE COMPARATOR

HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1. There are 4 planned dose levels: 0.001 mg/kg → 0.1 mg/kg.

Drug: Placebo comparator: HB2198 Diluent

HB2198 Diluent (IV)

PLACEBO COMPARATOR

HB2198 Diluent administered via IV infusion on Day 1

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

Interventions

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.

HB2198 Diluent (IV)

Placebo comparator: HB2198 Diluent DRUG

HB2198 Diluent: single IV infusion

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

Eligibility Criteria

• Age: Up to 55 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Hinge Bio: lead

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

RECRUITING

Central Study Contacts

Joshua Pelham

CONTACT

1-415-378-4738; joshua.pelham@hingebio.com

Kristen Quigley

CONTACT

kristen.quigley@hingebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HB2198 and HB2198 Diluent (Placebo)

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

AU (1)