Trials / Completed
CompletedNCT03976115
A Study to Evaluate the Safety and Efficacy of DDO-3055 in Healthy Volunteers and Patients With Chronic Kidney Disease
A Randomized, Double-Blind, Dose-escalating, Placebo Controlled, Phase I Study to Evaluate the Safety and Pharmacokinetics and Pharmacodynamics of DDO-3055 in Healthy Volunteers and Patients With Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DDO-3055 | Oral |
| DRUG | Placebos | Oral |
Timeline
- Start date
- 2019-07-18
- Primary completion
- 2021-05-11
- Completion
- 2021-05-11
- First posted
- 2019-06-05
- Last updated
- 2022-06-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03976115. Inclusion in this directory is not an endorsement.