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Status unknownNCT04775615Updated Mar 1, 2021

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

A Phase 1 interventional study of DDO-3055 tablets；Placebo and DDO-3055 tablets；Placebo in Renal Anemia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-03-01.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Anemia
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    Drug: DDO-3055 tablets；Placebo

  • Experimental
    Treatment group B

    Drug: DDO-3055 tablets；Placebo

  • Experimental
    Treatment group C

    Drug: DDO-3055 tablets；Placebo

Interventions

  • DrugDDO-3055 tablets；Placebo

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

  • DrugDDO-3055 tablets；Placebo

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

  • DrugDDO-3055 tablets；Placebo

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

06

What researchers measure

Primary outcomes

  1. Number of Subjects with Adverse Events (AE)

    Time frame: up to 14 days

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 7

    Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  2. Peak plasma concentration (Cmax) on Day 1 and Day 7

    Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  3. Time to maximum plasma concentration (Tmax) on Day 1 and Day 7

    Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  4. Change of endogenous erythropoietin from baseline :Day 1 and Day 7

    Time frame: 0, 24 hours post dose

  5. Change of VEGF from baseline :Day 1 and Day 7

    Time frame: 0, 24 hours post dose

  6. Change of Hb from baseline

    Time frame: Day1, Day7, Day14

  7. Change of Ret from baseline

    Time frame: Day1, Day7, Day14

  8. Change of Hepcidin from baseline

    Time frame: Day1, Day 9

  9. Change of Ferritin from baseline

    Time frame: Day1, Day 9

  10. Change of Serum Iron from baseline

    Time frame: Day1, Day 9

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04775615
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Mar 1, 2021
Start date
Mar 17, 2021 (estimated)
Primary completion
May 31, 2021 (estimated)
Completion
Jun 1, 2021 (estimated)
Last update
Mar 1, 2021

Study contacts

Chang Su
Contact
suchang@hrglobe.cn
+86 156 9951 7837
Junye Xiong
Contact
xiongjunye@hrglobe.cn
+86 180 3661 8716

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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