NCT03976115
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- DDO-3055
- Conditions
- Chronic Kidney Disease
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Adverse Events(AEs) and Serious Adverse Events （SAEs）
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers:
- •Male or female volunteers aged 18 to 45 years of age inclusive ; Hemoglobin is 120 to 160 g/L; In good health, at the discretion of the investigator, as determined by: medical history, physical examination, vital sign assessment, 12-lead ECG, clinical laboratory evaluations.
- •Patients with chronic kidney disease : Male or female patients with chronic kidney disease who are 18 to 45 years of age inclusive; Hemoglobin is ≤100 g/L; 30mL/min/1.73m2 ≤ eGFR ≤ 60mL/min/1.73m2（according to CKD-EPI formula）;
- •Body weight is ≥ 50kg, and 19kg/m2 ≤ body mass index\<26kg/m2 .
- •Normal iron reserves (serum iron \>61 g/dL and serum ferritin normal \>30ng/mL).
- •Signed informed consent.
Exclusion Criteria
- •Healthy volunteers:
- •The serum creatinine exceeded the upper limit of normal value in the screening period.
- •Healthy volunteers and patients with chronic kidney disease:
- •Allergic to the study drug or any of its ingredients.
- •Treating or treated with erythropoiesis stimulating agents for 1 month before screening.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) or total bilirubin above 1.5 times normal upper limit (ULN) in the screening period.
- •Have a history of blood donation or blood transfusion within 3 months.
- •Vein blood collection is difficult or physical condition can not afford blood collection.
- •Hepatitis b surface antigen (HBsAg), hepatitis c antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody test is positive in the screening period.
- •Smoking 5 cigarettes per day on average within 3 months; or the average daily intake of alcohol within one week is more than 15g (15g alcohol is equivalent to 450mL beer or 150mL wine or 50mL low-alcohol liquor) or 2 days before taking the study drug and during the study period, tobacco, alcohol and caffeinated food or beverage are not prohibited, or those with special dietary requirements cannot comply with the unified diet.
Arms & Interventions
1. healthy volunteers
3x single dose of DDO-3055 and placebo
Intervention: DDO-3055
1. healthy volunteers
3x single dose of DDO-3055 and placebo
Intervention: Placebos
2. Patients with chronic kidney disease
3x single dose of DDO-3055 and placebo
Intervention: DDO-3055
2. Patients with chronic kidney disease
3x single dose of DDO-3055 and placebo
Intervention: Placebos
Outcomes
Primary Outcomes
Adverse Events(AEs) and Serious Adverse Events （SAEs）
Time Frame: from informed consent form signature to the end of the study (up to 14 days)
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events
Secondary Outcomes
- Maximum observed serum concentration (Cmax) of DDO-3055(Pre-dose to 72 hours after dose administration)
- Changes in reticulocyte count relative to baseline(up to 14 days)
- Time to maximum observed serum concentration (tmax) of DDO-3055(Pre-dose to 72 hours after dose administration)
- Time to elimination half-life (t1/2) of DDO-3055(Pre-dose to 72 hours after dose administration)
- Apparent volume of distribution after non-intravenous administration (V/F) of DDO-3055(Pre-dose to 72 hours after dose administration)
- Renal clearance of the drug from plasma (CLR) of DDO-3055(Pre-dose to 72 hours after dose administration)
- Changes in red blood cell count relative to baseline(up to 14 days)
- Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055(Pre-dose to 72 hours after dose administration)
- Area under the plasma concentration versus time curve (AUC) of DDO-3055(Pre-dose to 72 hours after dose administration)
- Changes in hemoglobin relative to baseline(up to 14 days)
- Changes in endogenous erythropoietin relative to baseline(up to 14 days)
Study Sites (1)
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