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First-in-human Trial of RBD2080 in Healthy Participants
Sponsor: Suzhou Ribo Life Science Co. Ltd.
Summary
The goal of this clinical trial is to evaluate the safety, tolerability, dose-dependent pharmacokinetics and pharmacodynamics effects of RBD2080 in healthy volunteers to inform its further development for the treatment of patients with complement-mediated diseases. Participants will: * Be vaccinated against encapsulated bacterial infection prior to any IMP administration * Receive single or multiple doses of RBD2080 or placebo and attend 10-11 visits to the trial site for checkups and tests until End of trial (EoT). * Following End of trial visit, participants may enter an open-label follow-up period consisting of additional outpatient visits.
Official title: A Phase 1, Randomized, Single-blind, Single-center, Placebo-controlled First-in-human Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RBD2080 in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-08-19
Completion Date
2028-03-31
Last Updated
2026-10-13
Healthy Volunteers
Yes
Conditions
Interventions
Placebo
Subcutaneously Administered placebo in Healthy Subjects
RBD2080
Subcutaneously Administered RBD2080 in Healthy Subjects
Locations (1)
CMAX Clinical Research
Adelaide, South Australia, Australia