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

NCT04775615 | Unknown Phase 1

• 1 other identifier: DDO-3055-105
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Anemia

Outcome Measures

Primary Outcomes (1)

• Number of Subjects with Adverse Events (AE)

  up to 14 days

Secondary Outcomes (10)

• 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

Study Arms (3)

Treatment group A

EXPERIMENTAL

Drug: DDO-3055 tablets；Placebo

Treatment group B

EXPERIMENTAL

Drug: DDO-3055 tablets；Placebo

Treatment group C

EXPERIMENTAL

Drug: DDO-3055 tablets；Placebo

Interventions

DDO-3055 tablets；Placebo DRUG

Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days

Treatment group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged 18-45 years;
• Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2;
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Central Study Contacts

Chang Su

CONTACT

+86 156 9951 7837; suchang@hrglobe.cn

Junye Xiong

CONTACT

+86 180 3661 8716; xiongjunye@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-dose, dose escalation study in healthy subjects.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 1, 2021
• Study Start: March 17, 2021
• Primary Completion: May 31, 2021
• Study Completion: June 1, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02