Healthy VolunteerPhase 1NCT07439263
Single Ascending Dose Study of HB2198 in Healthy Participants
A Phase 1 study testing HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains in people with Healthy Volunteer, run by Hinge Bio at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Mar 2026to 21 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristen Quigley contact
Australia1 site, 1 recruiting
- Recruiting
Veritus Research
Bayswater, Victoria, 3153
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains, Placebo comparator: HB2198 Diluent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc DomainsDrug
Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1.
Placebo comparator: HB2198 DiluentDrug
HB2198 Diluent: single IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo comparator: HB2198 Diluent |
| HB2198 Diluent (IV) | Placebo comparator | HB2198 Diluent administered via IV infusion on Day 1 Receives: Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence/severity of AEs and SAEs (CTCAE v5.0)
Measured: Time Frame: Day 1 to Day 28; may extend to Month 2
Dose Limiting Toxicities (DLTs)
DLT's as defined within the protocol.
Measured: Day 1 through Day 28
Secondary outcomes (6)
To characterize the pharmacokinetic (PK) profile of HB2198
Area under the concentration versus time curve (AUC)
Measured: Day 1 to Month 2
To characterize the pharmacokinetic (PK) profile of HB2198
Maximum drug concentration (Cmax)
Measured: Day 1 to Month 2
To characterize the pharmacokinetic (PK) profile of HB2198
Time to maximum plasma concentration (tmax)
Measured: Day 1 to Month 2
To characterize the pharmacokinetic (PK) profile of HB2198:
Area Under the Curve to last measurable concentration (AUClast)
Measured: Day 1 to Month 2
To evaluate the development of anti-drug antibodies (ADAs)
ADA incidence
Measured: Day 1 to Month 2
To evaluate B-cell depletion and other pharmacodynamic changes
B-cell depletion and subsets; duration; change in total immunoglobulins; cytokines/CRP and other biomarkers.
Measured: Day 1 to Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start19 Mar 2026
- Primary completion14 Aug 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HB2198 and HB2198 Diluent (Placebo)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinge Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439263
- Sponsor's protocol ID
- HB2198-002
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is still being actively discussed. A decision will be made during the course of the study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07439263
- Acronym / sponsor ID
- HB2198-002
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hinge BioIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HB2198 and HB2198 Diluent (Placebo)
| Arm | Type | Receives |
|---|---|---|
| HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains | Active comparator | Drug: Placebo comparator: HB2198 DiluentHB2198, 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. |
| HB2198 Diluent (IV) | Placebo comparator | Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc DomainsHB2198 Diluent administered via IV infusion on Day 1 |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc DomainsDrug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1. | Drug | HB2198 Diluent (IV) |
| Placebo comparator: HB2198 DiluentHB2198 Diluent: single IV infusion | Drug | HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains |
Primary outcome
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)
Dose Limiting Toxicities (DLTs)
Time frame: Day 1 through Day 28
DLT's as defined within the protocol.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided. This is still being actively discussed. A decision will be made during the course of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen Quigley contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains in people with Healthy Volunteer, run by Hinge Bio at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Pelham (1-415-378-4738, joshua.pelham@hingebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Time Frame: Day 1 to Day 28; may extend to Month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.