Clinical Trial

A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects

Active, Not Recruiting Phase 1
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Record status
This record was last updated December 3, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a Randomized, Single-blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD4059 in Healthy Subjects. The study will be performed in single ascending dose (SAD) phase in healthy subjects. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information and PK/PD data in each cohort. RBD4059, a GalNAc conjugated siRNA, is an FXI-targeted new molecular entity independently developed by Ribo using its proprietary siRNA delivery system - RIBO-GalSTARTM.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-12-07; most recent amendment 2024-12-01.
Status change: Recruiting → Active, Not Recruiting 2024-12-01
Status change: Not Yet Recruiting → Recruiting 2023-10-19
Trial Details
NCT Number NCT05653037
Lead Sponsor Suzhou Ribo Life Science Co. Ltd.
Conditions Healthy Volunteers
Enrollment 32 participants
Start Date 2023-03-21
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-03