Anemia in Chronic Kidney DiseasePhase 1NCT04197778
Food Effect Study of DDO-3055 Tablets in Healthy Subjects
A Phase 1 study testing DDO-3055 tablet in people with Anemia in Chronic Kidney Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is a randomized , open-label, two-stage crossover food effect study of single doses of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups A and B, 7 subjects in each group. Two stage washout period is 6 days. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia in Chronic Kidney Disease
- What is being tested?
- DDO-3055 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 18 Jan 2020
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy male volunteers, aged 18~45.
- 2. Body weight ≥ 50 kg, body mass index (BMI) between 18 to 28.
- 3. Hemoglobin is in the normal range.
- 4. Signed informed consent.
Who cannot join
- 1. Vital signs, physical examination, laboratory results are abnormal and clinically significant.
- 2. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
- 3. Suspected allergy to the active ingredient or excipient of the experimental drug.
- 4. Have used erythropoietin within 1 month prior to screening or are currently using erythropoietin.
- 5. Had donated blood or blood transfusion within 3 months prior to screening.
- 6. Vein blood collection is difficult or physical condition can not afford blood collection.
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- 7. Hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCVAb), Syphilis antibody, human immunodeficiency virus antibody (HIVAb)were positive.
- 8. Average daily smoking ≥5 cigarettes within 3 months before screening; 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 trial take the tobacco and alcohol and caffeinated foods or drinks, and have special dietary requirements and cannot follow a uniform diet.
- 9. 3 months prior to screening involved in any drug or medical device clinical trials, or within 5 half-life of drugs before screening.
- 10. Any health care products, Over-the-counter drugs or prescription drugs that affects the absorption, distribution, metabolism and excretion of the experimental drug was used within 1 month before the administration.
- 11. With a history of drug abuse or screening visit/baseline visit urine drug abuse screening positive.
- 12. Subjects who are unwilling to take contraceptives or who are likely to donate sperm during the trial and within 30 days after administration; or who do not agree to physical contraception during the trial.
- 13. Other conditions in which the study physician considered the subject not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
About this study
The study is a randomized , open-label, two-stage crossover food effect study of single doses of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups A and B, 7 subjects in each group. Two stage washout period is 6 days.
- Conditions
- Anemia in Chronic Kidney Disease
- Being tested
- DDO-3055 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDO-3055 tabletDrug
DDO-3055 tablet, 2 single doses separated by 6 days.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Not described Receives: Drug: DDO-3055 tablet |
| group B | Experimental | Not described Receives: Drug: DDO-3055 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) of DDO-3055
Measured: up to 2 days
Maximum plasma concentration (Cmax) of DDO-3055
Measured: up to 2 days
Time to maximum observed serum concentration (Tmax) of DDO-3055
Measured: up to 2 days
Terminal elimination half-life (T1/2) of DDO-3055
Measured: up to 2 days
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Measured: up to 2 days
Apparent volume of distribution after oral administration (V/F) of DDO-3055
Measured: up to 2 days
Secondary outcomes (2)
Change of endogenous erythropoietin from baseline
Measured: up to 2 days
Safety and tolerability
Use the incidence and severity of adverse events to assess safety and tolerability
Measured: up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start6 Jan 2020
- Primary completion18 Jan 2020
- Study completion18 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT04197778
- Sponsor's protocol ID
- DDO-3055-102
- Status last verified
- Jun 2022
- First submitted
- 3 Dec 2019
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Effect Study of DDO-3055 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04197778
- Acronym / sponsor ID
- DDO-3055-102
- Conditions
- Anemia in Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 18 Jan 2020 (actual)
- Study completion
- 18 Jan 2020 (actual)
- First posted
- 13 Dec 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.
The study is a randomized , open-label, two-stage crossover food effect study of single doses of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups A and B, 7 subjects in each group. Two stage washout period is 6 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: DDO-3055 tablet |
| group B | Experimental | Drug: DDO-3055 tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Healthy male volunteers, aged 18~45.
- 2. Body weight ≥ 50 kg, body mass index (BMI) between 18 to 28.
- 3. Hemoglobin is in the normal range.
- 4. Signed informed consent.
Key exclusion criteria (13 listed)
- 1. Vital signs, physical examination, laboratory results are abnormal and clinically significant.
- 2. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
- 3. Suspected allergy to the active ingredient or excipient of the experimental drug.
- 4. Have used erythropoietin within 1 month prior to screening or are currently using erythropoietin.
- 5. Had donated blood or blood transfusion within 3 months prior to screening.
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-3055 tabletDDO-3055 tablet, 2 single doses separated by 6 days. | Drug | group A, group B |
Primary outcome
Area under the concentration-time curve (AUC) of DDO-3055
Time frame: up to 2 days
Maximum plasma concentration (Cmax) of DDO-3055
Time frame: up to 2 days
Time to maximum observed serum concentration (Tmax) of DDO-3055
Time frame: up to 2 days
Terminal elimination half-life (T1/2) of DDO-3055
Time frame: up to 2 days
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Time frame: up to 2 days
Apparent volume of distribution after oral administration (V/F) of DDO-3055
Time frame: up to 2 days
2 secondary outcomes
Change of endogenous erythropoietin from baseline
Time frame: up to 2 days
Safety and tolerability
Time frame: up to 9 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 8 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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 tablet in people with Anemia in 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 4 inclusion and 13 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 8 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?
Area under the concentration-time curve (AUC) of DDO-3055 (time frame: up to 2 days). The study lists 6 primary outcomes in all. 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 8 Jun 2022.