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
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
Treatments tested in this trial
- HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains
- Placebo comparator: HB2198 Diluent
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov