Actively Recruiting
Single Ascending Dose Study of HB2198 in Healthy Participants
Led by Hinge Bio · Updated on 2026-04-13
32
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Single Ascending Dose Study of HB2198 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years
- Healthy individuals
- IgG level of at least 600 mg/dL
- Peripheral B cell count within normal laboratory range
- Negative pregnancy test for women of childbearing potential
- Use of contraception as specified in the protocol
- Ability to stay confined from one day before dosing through at least 24 hours after dosing
- Provided informed consent
You will not qualify if you...
- Presence of any clinically significant disease impacting safety or study data
- Low immunoglobulin levels (hypogammaglobulinemia) or active/recent significant infection
- Use of chronic antiviral or antimicrobial medications
- Recent major surgery or receipt of live vaccines within 30 days (inactivated vaccines should be at least 14 days prior to dosing)
- Positive tuberculosis screening without treatment
- Positive tests for hepatitis B virus DNA, hepatitis C virus RNA, or HIV infection
- Pregnancy or breastfeeding
- Planning conception or gamete donation within 6 months after dosing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
Research Team
J
Joshua Pelham
CONTACT
K
Kristen Quigley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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