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

NCT04775615 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-03-01

No results posted yet for this 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.

Conditions

  • Renal Anemia

Interventions

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2021-05-31
Completion
2021-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04775615 on ClinicalTrials.gov