Status:
UNKNOWN
Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Healthy Subjects.
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Renal Anemia
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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
- Healthy volunteers aged 18-45 years;
- Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2;
- Signed informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04775615
Start Date
March 17 2021
End Date
June 1 2021
Last Update
March 1 2021
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