NCT07439263 Single Ascending Dose Study of HB2198 in Healthy Participants
| NCT ID | NCT07439263 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hinge Bio |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2026-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-03-19 with a primary completion date of 2026-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
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: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07439263 clinical trial?
This trial is open to participants of all sexes, up to 55 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07439263 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07439263 currently recruiting?
Yes, NCT07439263 is actively recruiting participants. Contact the research team at joshua.pelham@hingebio.com for enrollment information.
Where is the NCT07439263 trial being conducted?
This trial is being conducted at Bayswater, Australia.
Who is sponsoring the NCT07439263 clinical trial?
NCT07439263 is sponsored by Hinge Bio. The trial plans to enroll 32 participants.