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A Double blind, Randomized, Placebo controlled, Single dose, Dose ascending Phase I Study to Evaluate the Safety, Tolerability and Pharmacodynamics (PD) of Niclosamide injectable (DWRX2003) following Intramuscular Administration in COVID-19 Patients

PHRR201005-002955

NCT04541485

2020-CT0551

To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)

This Phase I study is a prospective, double blind, randomized, placebo controlled study designed to assess the safety, tolerability, and pharmacodynamics (PD) of single intramuscular doses of DWRX2003 in COVID-19 patients. This study will be conducted in 5 cohorts in COVID-19 patients. The study will be conducted in low and moderate risk COVID-19 patients, between 18 and 65 years of age, using a double blind, randomized, placebo controlled design. This part of the study will include a double blind assessment of the safety, tolerability and pharmacodynamics (PD) of DWRX2003.

Start Date Duration in Months Target Completion Date Actual Completion Date
2020-09-25 1 2020-10-25 2021-03-23

Terminated

Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.

Institution Classification Region LTO #
Daewoong Pharmaceutical Co., Ltd. Private Business South Korea LTO-3000004121933
Institution Region
Daewoong Pharmaceutical Co., Ltd. South Korea
Name E-Mail Institution and Institution Address
Daewoong Pharmaceutical Co., Ltd. kjkim103@daewoong.co.kr 644, Bongeunsa-ro, Gangnam-gu, Seoul, Korea
Name E-Mail Institution and Institution Address
Ryan Marte Llorin M.D. drryanllorin@gmail.com St. Luke’s Medical Center – Global Taguig City Rizal Drive cor. 32nd St. and 5th Ave., Taguig, 1634
Name Expertise Affiliation
Ryan Marte Llorin M.D. Infectious Diseases Physician St Luke Medical Center - Global City
Project Location Institutional Ethics Review Board
St Luke Medical Center - Global City N/A

For the subject inclusion criteria, only those who have voluntarily consented to the ICF between the ages of 18 and 65 and then have have passed the screening test specified in the protocol among those who have been found to have low to moderate risk of COVID-19 infection can participate in the clinical trial.

The primary objective of this study is to assess the safety and tolerability of Niclosamide injectable (DWRX2003) following single dose of DWRX2003 in COVID-19 patients.

Unspecified

Terminated

Clinical Trial

NCT04541485

Unspecified

0000-00-00

0000-00-00

40

Unspecified

Unspecified

2020-12-04

Inclusion Criteria:

  1. Between 18 and 65 years of age, inclusive at time of signing the ICF.

  2. Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment.

Exclusion Criteria:

  1. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).

  2. Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study

Interventional

Parallel Assignment

Double Making (Participant, Investigator)

None

Randomized

Double Blind

Unspecified

Parallel

Treatment of patients with COVID-19.

Phase I

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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