Status:
UNKNOWN
To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in ...
Eligibility Criteria
Inclusion
- Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
- Volunteers who agree to give written informed consent and are willing to participate in the study.
- Volunteer having bodyweight minimum of 50 kg.
- Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).
Exclusion
- Known allergic to Niclosamide or any component of the formulation and to any other related drug.
- History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
- History/ current use of Alcohol or drug abuse.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04524052
Start Date
August 1 2020
End Date
December 1 2020
Last Update
August 24 2020
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