Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Healthy Subjects.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Renal Anemia

Intervention / Treatment
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* Drug: DDO-3055 tablets；Placebo
* Drug: DDO-3055 tablets；Placebo
* Drug: DDO-3055 tablets；Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged 18-45 years; Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2; Signed informed consent. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multi-dose, dose escalation study in healthy subjects.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: DDO-3055 tablets；Placebo<br>* Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days<br>|
| Experimental: Treatment group B<br> | Drug: DDO-3055 tablets；Placebo<br>* Medium dose：DDO-3055 tablets for 7 days or Placebo for 7 days<br>|
| Experimental: Treatment group C<br> | Drug: DDO-3055 tablets；Placebo<br>* High dose：DDO-3055 tablets for 7 days or Placebo for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Adverse Events (AE) |  | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change of Hb from baseline |  | Day1, Day7, Day14 | 
| 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 |