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

Renal Anemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04775615
• Other study ID #: DDO-3055-105
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 17, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Chang Su
• Phone: +86 156 9951 7837
• Email: suchang[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 1, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Anemia

Intervention

Drug:
• DDO-3055 tablets;Placebo
Low dose:DDO-3055 tablets for 7 days or Placebo for 7 days
• DDO-3055 tablets;Placebo
Medium dose:DDO-3055 tablets for 7 days or Placebo for 7 days
• DDO-3055 tablets;Placebo
High dose:DDO-3055 tablets for 7 days or Placebo for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Adverse Events (AE)		up to 14 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of endogenous erythropoietin from baseline :Day 1 and Day 7		0, 24 hours post dose
Secondary	Change of VEGF from baseline :Day 1 and Day 7		0, 24 hours post dose
Secondary	Change of Hb from baseline		Day1, Day7, Day14
Secondary	Change of Ret from baseline		Day1, Day7, Day14
Secondary	Change of Hepcidin from baseline		Day1, Day 9
Secondary	Change of Ferritin from baseline		Day1, Day 9
Secondary	Change of Serum Iron from baseline		Day1, Day 9