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

Phase 1

• Conditions: Renal Anemia
• Interventions: Drug: DDO-3055 tablets；Placebo

• Registration Number: NCT04775615
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01
• Study Start: 2021-03-17
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment group A	DDO-3055 tablets；Placebo	-
Treatment group B	DDO-3055 tablets；Placebo	-
Treatment group C	DDO-3055 tablets；Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Adverse Events (AE)	up to 14 days

Secondary Outcome Measures

Name	Time	Method
Change of Hb from baseline	Day1, Day7, Day14
Change of endogenous erythropoietin from baseline :Day 1 and Day 7	0, 24 hours post dose
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 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
Change of Serum Iron from baseline	Day1, Day 9
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