Single Ascending Dose Study of HB2198 in Healthy Participants
Recruiting
Phase 1
Interventional Study
Healthy Volunteer
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- Up to 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 32 (estimated)
- Sponsor
- Hinge Bio · Industry
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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 coun…
Trial Locations
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Eligibility Criteria
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:
* Clinical…
Contacts