Food Effect Study of DDO-3055 Tablets in Healthy Subjects

Study Overview
=================
Brief 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.

Official Title
-----------------
Food Effect Study of DDO-3055 Tablets in Healthy Subjects

Conditions
-----------------
Anemia in Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: DDO-3055 tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br> | Drug: DDO-3055 tablet<br>* DDO-3055 tablet, 2 single doses separated by 6 days.<br>|
| Experimental: group B<br> | Drug: DDO-3055 tablet<br>* DDO-3055 tablet, 2 single doses separated by 6 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC) of DDO-3055 |  | up to 2 days | 
| Maximum plasma concentration (Cmax) of DDO-3055 |  | up to 2 days | 
| Time to maximum observed serum concentration (Tmax) of DDO-3055 |  | up to 2 days | 
| Terminal elimination half-life (T1/2) of DDO-3055 |  | up to 2 days | 
| Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055 |  | up to 2 days | 
| Apparent volume of distribution after oral administration (V/F) of DDO-3055 |  | up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of endogenous erythropoietin from baseline |  | up to 2 days | 
| Safety and tolerability | Use the incidence and severity of adverse events to assess safety and tolerability | up to 9 days |