Renal Anemia
Conditions
Brief 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.
Interventions
DRUGDDO-3055 tablets；Placebo
Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multi-dose, dose escalation study in healthy subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy volunteers aged 18-45 years; 2. Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2; 3. Signed informed consent.
Exclusion criteria
1. Allergic constitution, suspected to be allergic to the study drug or any component in the study drug; 2. 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 ； 3. Subjects with a value at screening is greater than the upper limit of reference range for serum creatinine; 4. Subjects with a positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening； 5. Subjects with blood loss ≥400mL within 3 months before screening; 6. 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. 7. 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; 8. Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening. 9. 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; 10. Drug abusers or drug urine screening positive; 11. The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects with Adverse Events (AE) | up to 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum plasma concentration (Tmax) on Day 1 and Day 7 | Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose |
| Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 7 | 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 | 0, 24 hours post dose |
| Change of VEGF from baseline :Day 1 and Day 7 | 0, 24 hours post dose |
| Peak plasma concentration (Cmax) on Day 1 and Day 7 | Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose |
| Change of Ret from baseline | Day1, Day7, Day14 |
| Change of Hepcidin from baseline | Day1, Day 9 |
| Change of Ferritin from baseline | Day1, Day 9 |
| Change of Serum Iron from baseline | Day1, Day 9 |
| Change of Hb from baseline | Day1, Day7, Day14 |
Contacts
Primary ContactChang Su
Backup ContactJunye Xiong
Outcome results
None listed