drugset / Trial / NCT05912296

A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022

NCT05912296 ↗

Phase 1 Completed 80 enrolled Suzhou Ribo Life Science Co. Ltd.
RandomizedSequentialSingle-blindTreatment

Summary

This is a randomized, single blind, placebo controlled, single center phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of subcutaneously administered RBD7022 in participants with normal or elevated LDL-c cholesterol. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in participants. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information in each cohort.

Timeline

Start
2023-05-30
Primary completion
2025-03-04
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject RBD7022 Unknown — Subcutaneous

Indications