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RECRUITING
NCT07869940
PHASE1

First-in-human Trial of RBD2080 in Healthy Participants

Sponsor: Suzhou Ribo Life Science Co. Ltd.

View on ClinicalTrials.gov

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

DRUG

Placebo

Subcutaneously Administered placebo in Healthy Subjects

DRUG

RBD2080

Subcutaneously Administered RBD2080 in Healthy Subjects

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia