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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Renal Anemia
• Intervention / Treatment: Drug: DDO-3055 tablets；Placebo; Drug: DDO-3055 tablets；Placebo; Drug: DDO-3055 tablets；Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chang Su; Phone Number: +86 156 9951 7837; Email: suchang@hrglobe.cn
• Study Contact Backup: Name: Junye Xiong; Phone Number: +86 180 3661 8716; Email: xiongjunye@hrglobe.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group A	Drug: DDO-3055 tablets；Placebo; Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days; Drug: DDO-3055 tablets；Placebo; Medium dose：DDO-3055 tablets for 7 days or Placebo for 7 days; Drug: DDO-3055 tablets；Placebo; High dose：DDO-3055 tablets for 7 days or Placebo for 7 days
EXPERIMENTAL: Treatment group B	Drug: DDO-3055 tablets；Placebo; Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days; Drug: DDO-3055 tablets；Placebo; Medium dose：DDO-3055 tablets for 7 days or Placebo for 7 days; Drug: DDO-3055 tablets；Placebo; High dose：DDO-3055 tablets for 7 days or Placebo for 7 days
EXPERIMENTAL: Treatment group C	Drug: DDO-3055 tablets；Placebo; Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days; Drug: DDO-3055 tablets；Placebo; Medium dose：DDO-3055 tablets for 7 days or Placebo for 7 days; Drug: DDO-3055 tablets；Placebo; High dose：DDO-3055 tablets for 7 days or Placebo for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects with Adverse Events (AE)	up to 14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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 endogenous erythropoietin from baseline :Day 1 and Day 7	0, 24 hours post dose
Change of VEGF from baseline :Day 1 and Day 7	0, 24 hours post dose
Change of Hb from baseline	Day1, Day7, Day14
Change of Ret from baseline	Day1, Day7, Day14
Change of Hepcidin from baseline	Day1, Day 9
Change of Ferritin from baseline	Day1, Day 9
Change of Serum Iron from baseline	Day1, Day 9

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 17, 2021
• Primary Completion (ANTICIPATED): May 31, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (ACTUAL): March 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DDO-3055-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No