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Single Ascending Dose Study of HB2198 in Healthy Participants

ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 55
SponsorHinge Bio

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc DomainsActive comparator 1 intervention
Group B: HB2198 Diluent (IV)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability

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

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

Dose Limiting Toxicities (DLTs)

DLT's as defined within the protocol.

Time frame
Day 1 through Day 28

Secondary outcomes

1

To characterize the pharmacokinetic (PK) profile of HB2198

Area under the concentration versus time curve (AUC)

Time frame
Day 1 to Month 2
2

To characterize the pharmacokinetic (PK) profile of HB2198

Maximum drug concentration (Cmax)

Time frame
Day 1 to Month 2
3

To characterize the pharmacokinetic (PK) profile of HB2198

Time to maximum plasma concentration (tmax)

Time frame
Day 1 to Month 2
4

To characterize the pharmacokinetic (PK) profile of HB2198:

Area Under the Curve to last measurable concentration (AUClast)

Time frame
Day 1 to Month 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hinge Bio

Lead sponsor

Source ClinicalTrials.gov
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