Clinical trial NCT04775615: Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Healthy Subjects.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Renal Anemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multi-dose, dose escalation study in healthy subjects.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects with Adverse Events (AE)
timeFrame: up to 14 days
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 7
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Peak plasma concentration (Cmax) on Day 1 and Day 7
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Time to maximum plasma concentration (Tmax) on Day 1 and Day 7
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Change of endogenous erythropoietin from baseline :Day 1 and Day 7
timeFrame: 0, 24 hours post dose
measure: Change of VEGF from baseline :Day 1 and Day 7
timeFrame: 0, 24 hours post dose
measure: Change of Hb from baseline
timeFrame: Day1, Day7, Day14
measure: Change of Ret from baseline
timeFrame: Day1, Day7, Day14
measure: Change of Hepcidin from baseline
timeFrame: Day1, Day 9
measure: Change of Ferritin from baseline
timeFrame: Day1, Day 9
measure: Change of Serum Iron from baseline
timeFrame: Day1, Day 9
Other outcomes:
Locations:
Study officials:
References: