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.

Jiangsu HengRui Medicine Co., Ltd.0 sites36 target enrollmentMarch 17, 2021

ConditionsRenal Anemia

InterventionsDDO-3055 tablets；Placebo

DrugsDDO-3055 tablets；Placebo

Overview

Phase: Phase 1
Intervention: DDO-3055 tablets；Placebo
Conditions: Renal Anemia
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 36
Primary Endpoint: Number of Subjects with Adverse Events (AE)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 17, 2021

End Date

June 1, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Treatment group A

Intervention: DDO-3055 tablets；Placebo

Treatment group B

Intervention: DDO-3055 tablets；Placebo

Treatment group C

Intervention: DDO-3055 tablets；Placebo

Outcomes

Primary Outcomes

Number of Subjects with Adverse Events (AE)

Time Frame: up to 14 days

Secondary Outcomes

Change of Ret from baseline(Day1, Day7, Day14)
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 endogenous erythropoietin from baseline :Day 1 and Day 7(0, 24 hours post dose)
Change of Hepcidin from baseline(Day1, Day 9)
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 VEGF from baseline :Day 1 and Day 7(0, 24 hours post dose)
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)