Renal AnemiaPhase 1NCT04775615
Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Healthy Subjects.
A Phase 1 study of Renal Anemia, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Renal Anemia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2021to 1 Jun 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy volunteers aged 18-45 years;
- Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2;
- Signed informed consent.
Who cannot join
- Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
- A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, Total bilirubin, direct bilirubin, indirect bilirubin ；
- Subjects with a value at screening is greater than the upper limit of reference range for serum creatinine;
- Subjects with a positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；
- Subjects with blood loss ≥400mL within 3 months before screening;
- Subjects has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study.
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- Participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;
- Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening.
- Smokers (average daily smoking 5 or more); Subjects who consumed more than 15 grams of alcohol per day within one week prior to the screening;
- Drug abusers or drug urine screening positive;
- The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multi-dose DDO-3055 Tablets in Healthy Subjects-Randomized, Double-blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days.
- Conditions
- Renal Anemia
- Being tested
- DDO-3055 tablets；Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDO-3055 tablets；PlaceboDrug
Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days
DDO-3055 tablets；PlaceboDrug
Medium dose：DDO-3055 tablets for 7 days or Placebo for 7 days
DDO-3055 tablets；PlaceboDrug
High dose：DDO-3055 tablets for 7 days or Placebo for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: DDO-3055 tablets；Placebo |
| Treatment group B | Experimental | Not described Receives: Drug: DDO-3055 tablets；Placebo |
| Treatment group C | Experimental | Not described Receives: Drug: DDO-3055 tablets；Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Adverse Events (AE)
Measured: up to 14 days
Secondary outcomes (10)
Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 7
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Peak plasma concentration (Cmax) on Day 1 and Day 7
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Time to maximum plasma concentration (Tmax) on Day 1 and Day 7
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Change of endogenous erythropoietin from baseline :Day 1 and Day 7
Measured: 0, 24 hours post dose
Change of VEGF from baseline :Day 1 and Day 7
Measured: 0, 24 hours post dose
Change of Hb from baseline
Measured: Day1, Day7, Day14
Change of Ret from baseline
Measured: Day1, Day7, Day14
Change of Hepcidin from baseline
Measured: Day1, Day 9
Change of Ferritin from baseline
Measured: Day1, Day 9
Change of Serum Iron from baseline
Measured: Day1, Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start17 Mar 2021 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AnemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multi-dose, dose escalation study in healthy subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
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
- NCT04775615
- Sponsor's protocol ID
- DDO-3055-105
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multi-dose DDO-3055 Tablets in Healthy Subjects-Randomized, Double-blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial.
- ClinicalTrials.gov ID
- NCT04775615
- Acronym / sponsor ID
- DDO-3055-105
- Conditions
- Renal Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 1 Mar 2021 (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 being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Multi-dose, dose escalation study in healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: DDO-3055 tablets；Placebo |
| Treatment group B | Experimental | Drug: DDO-3055 tablets；Placebo |
| Treatment group C | Experimental | Drug: DDO-3055 tablets；Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged 18-45 years;
- Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2;
- Signed informed consent.
Key exclusion criteria (11 listed)
- Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
- A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, Total bilirubin, direct bilirubin, indirect bilirubin ；
- Subjects with a value at screening is greater than the upper limit of reference range for serum creatinine;
- Subjects with a positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；
- Subjects with blood loss ≥400mL within 3 months before 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 tablets；PlaceboLow dose：DDO-3055 tablets for 7 days or Placebo for 7 days | Drug | Treatment group A |
| DDO-3055 tablets；PlaceboMedium dose：DDO-3055 tablets for 7 days or Placebo for 7 days | Drug | Treatment group B |
| DDO-3055 tablets；PlaceboHigh dose：DDO-3055 tablets for 7 days or Placebo for 7 days | Drug | Treatment group C |
Primary outcome
Number of Subjects with Adverse Events (AE)
Time frame: up to 14 days
10 secondary outcomes
Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 7
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Peak plasma concentration (Cmax) on Day 1 and Day 7
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Time to maximum plasma concentration (Tmax) on Day 1 and Day 7
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Change of endogenous erythropoietin from baseline :Day 1 and Day 7
Time frame: 0, 24 hours post dose
Change of VEGF from baseline :Day 1 and Day 7
Time frame: 0, 24 hours post dose
Change of Hb from baseline
Time frame: Day1, Day7, Day14
Change of Ret from baseline
Time frame: Day1, Day7, Day14
Change of Hepcidin from baseline
Time frame: Day1, Day 9
Change of Ferritin from baseline
Time frame: Day1, Day 9
Change of Serum Iron from baseline
Time frame: Day1, Day 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Renal Anemia, run by Jiangsu HengRui Medicine Co., Ltd..
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Su (+86 156 9951 7837, suchang@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Adverse Events (AE) (time frame: 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 1 Mar 2021.