Chronic Kidney DiseasePhase 1NCT03976115
A Study to Evaluate the Safety and Efficacy of DDO-3055 in Healthy Volunteers and Patients With Chronic Kidney Disease
A Phase 1 study testing DDO-3055 in people with Chronic Kidney Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- DDO-3055
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2019to 11 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- DDO-3055, Placebos
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDO-3055Drug
Oral
PlacebosDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1. healthy volunteers | Experimental | 3x single dose of DDO-3055 and placebo Receives: Drug: DDO-3055; Drug: Placebos |
| 2. Patients with chronic kidney disease | Experimental | 3x single dose of DDO-3055 and placebo Receives: Drug: DDO-3055; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events(AEs) and Serious Adverse Events （SAEs）
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events
Measured: 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
Measured: Pre-dose to 72 hours after dose administration
Maximum observed serum concentration (Cmax) of DDO-3055
Measured: Pre-dose to 72 hours after dose administration
Time to maximum observed serum concentration (tmax) of DDO-3055
Measured: Pre-dose to 72 hours after dose administration
Time to elimination half-life (t1/2) of DDO-3055
Measured: Pre-dose to 72 hours after dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Measured: Pre-dose to 72 hours after dose administration
Apparent volume of distribution after non-intravenous administration (V/F) of DDO-3055
Measured: Pre-dose to 72 hours after dose administration
Renal clearance of the drug from plasma (CLR) of DDO-3055
Measured: Pre-dose to 72 hours after dose administration
Changes in red blood cell count relative to baseline
Measured: up to 14 days
Changes in reticulocyte count relative to baseline
Measured: up to 14 days
Changes in hemoglobin relative to baseline
Measured: up to 14 days
Changes in endogenous erythropoietin relative to baseline
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start18 Jul 2019
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976115
- Sponsor's protocol ID
- DDO-3055-101
- Status last verified
- Jun 2022
- First submitted
- 29 May 2019
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03976115
- Acronym / sponsor ID
- DDO-3055-101
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. healthy volunteers | Experimental | Drug: DDO-3055, Drug: Placebos3x single dose of DDO-3055 and placebo |
| 2. Patients with chronic kidney disease | Experimental | Drug: DDO-3055, Drug: Placebos3x single dose of DDO-3055 and placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- The serum creatinine exceeded the upper limit of normal value in the screening period.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDO-3055Oral | Drug | 1. healthy volunteers, 2. Patients with chronic kidney disease |
| PlacebosOral | Drug | 1. healthy volunteers, 2. Patients with chronic kidney disease |
Primary outcome
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
11 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Maximum observed serum concentration (Cmax) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Time to maximum observed serum concentration (tmax) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Time to elimination half-life (t1/2) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Apparent volume of distribution after non-intravenous administration (V/F) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Renal clearance of the drug from plasma (CLR) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Changes in red blood cell count relative to baseline
Time frame: up to 14 days
Changes in reticulocyte count relative to baseline
Time frame: up to 14 days
Changes in hemoglobin relative to baseline
Time frame: up to 14 days
Changes in endogenous erythropoietin relative to baseline
Time frame: up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DDO-3055 in people with Chronic Kidney Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.