drugset / Trial / NCT03976115

A Study to Evaluate the Safety and Efficacy of DDO-3055 in Healthy Volunteers and Patients With Chronic Kidney Disease

NCT03976115 ↗

Phase 1 Completed 54 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedSequentialDouble-blindBasic science

Summary

This is a randomized, double-blind, dose-escalating, placebo controlled, Phase I study to evaluate the safety, pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with chronic kidney disease. 48 healthy volunteers will be enrolled in Part A, and 18 patients with chronic kidney disease will be enrolled in Part B.

Timeline

Start
2019-07-18
Primary completion
2021-05-11
Completion
2021-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject DDO-3055 Small molecule — Oral