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

NCT03976115 | Completed Phase 1 DMC

• 1 other identifier: DDO-3055-101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Adverse Events(AEs) and Serious Adverse Events （SAEs）

  Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events

  from informed consent form signature to the end of the study (up to 14 days)

Secondary Outcomes (11)

• Area under the plasma concentration versus time curve (AUC) of DDO-3055

  Pre-dose to 72 hours after dose administration

• Maximum observed serum concentration (Cmax) of DDO-3055

  Pre-dose to 72 hours after dose administration

• 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 total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055

  Pre-dose to 72 hours after dose administration

Study Arms (2)

1. healthy volunteers

EXPERIMENTAL

3x single dose of DDO-3055 and placebo

Drug: DDO-3055; Drug: Placebos

2. Patients with chronic kidney disease

EXPERIMENTAL

3x single dose of DDO-3055 and placebo

Drug: DDO-3055; Drug: Placebos

Interventions

DDO-3055 DRUG

Oral

1. healthy volunteers; 2. Patients with chronic kidney disease

Placebos DRUG

Oral

1. healthy volunteers; 2. Patients with chronic kidney disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Those who have participated in clinical trials of any drug or medical device within 3 months prior to screening, or those who have participated in the drug trial within 5 half-lives prior to screening; any health product (within 1 week prior to administration), over-the-counter drug (2 weeks prior to administration) or prescription drug (1 month prior to administration) that affects the absorption, distribution, metabolism or excretion of the tested drug.
• With a history of drug abuse or positive screening/baseline test for substance abuse and drug urinalysis.
• During the study period and within 30 days after administration, men who are unwilling to take contraceptive measures and promise not to donate sperm are not allowed to participate in the study. Childbearing women who did not use contraception at least 14 days before administration; men and women who did not agree to use physical contraception during the study period.
• Women with serum HCG ≥ 5 mIU/mL or nursing in the screening period or baseline
• Any physical or mental illness or condition that may increase the risk of the study, affect the subject's compliance with the protocol, or affect the subject's ability to complete the study, as determined by the study physician.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 5, 2019
• Study Start: July 18, 2019
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

CN (1)