To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19
NCT ID: NCT04524052
Last Updated: 2020-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
32 participants
INTERVENTIONAL
2020-08-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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cohort 1 (144 mg)
Arms (both) 0.1 mL/site\*2 sites Hips (both) 0.2 mL/site\*2 sites
DWRX2003
Intramuscularly injection at pre-defined injection sites
Placebo
Intramuscularly injection at pre-defined injection sites
cohort 2 (432 mg)
Arms (both) 0.3 mL/site \*2 sites Hips (both) 0.6 mL/site\*2 sites
DWRX2003
Intramuscularly injection at pre-defined injection sites
Placebo
Intramuscularly injection at pre-defined injection sites
cohort 3 (960 mg)
Arms (both) 0.8 mL/site\*2 sites Hips (both) 1.2 mL/site\*2 sites
DWRX2003
Intramuscularly injection at pre-defined injection sites
Placebo
Intramuscularly injection at pre-defined injection sites
cohort 4 (1200 mg)
Arms (both) 1.0 mL/site \*2 sites Hips (both) 1.5 mL/site\*2 sites
DWRX2003
Intramuscularly injection at pre-defined injection sites
Placebo
Intramuscularly injection at pre-defined injection sites
Interventions
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DWRX2003
Intramuscularly injection at pre-defined injection sites
Placebo
Intramuscularly injection at pre-defined injection sites
Eligibility Criteria
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Inclusion Criteria
2. Volunteers who agree to give written informed consent and are willing to participate in the study.
3. Volunteer having bodyweight minimum of 50 kg.
4. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).
Exclusion Criteria
2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
3. Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
4. History/ current use of Alcohol or drug abuse.
18 Years
45 Years
ALL
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Other Identifiers
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DWJ1516101_India
Identifier Type: -
Identifier Source: org_study_id
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