Single Ascending Dose Study of HB2198 in Healthy Participants

NCT07439263 · tracked via the Priya Life Science Australia tracker

Sponsor

Hinge Bio

Phase

Phase 1

Started

2026-03-19

Last updated

2026-04-13

Condition(s) studied

Healthy Volunteer

Investigational drug(s) / intervention(s)

HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc DomainsPlacebo comparator: HB2198 Diluent

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.

Placebo comparator: HB2198 Diluent: HB2198 Diluent: single IV infusion

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.

Eligibility

Sex

ALL

Min age

—

Max age

55 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Safety and Tolerability — Time Frame: Day 1 to Day 28; may extend to Month 2
Incidence/severity of AEs and SAEs (CTCAE v5.0)
Dose Limiting Toxicities (DLTs) — Day 1 through Day 28
DLT's as defined within the protocol.

Trial sites (1)

Facility	City	Region	Status
Veritus Research	Bayswater	Victoria	Recruiting

More Hinge Bio trials in Australia

A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) Recruiting

Other trials for the same condition

A Phase 1 Study of S-4321 Recruiting

A Safety and Pharmacokinetics Study of TL-003 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis Recruiting

Supplementation Absorption Comparison Recruiting

First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers Active, not recruiting

A Study Testing the Safety and Effects of FB102 in Healthy Volunteers Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07439263 on ClinicalTrials.gov ↗ ← All trials in Australia