To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19

Healthy Clinical Trial

Official title:

Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04524052
• Other study ID #: DWJ1516101_India
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2020
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 healthy volunteers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.

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:

1. Known allergic to Niclosamide or any component of the formulation and to any other related drug.

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWRX2003
Intramuscularly injection at pre-defined injection sites
• Placebo
Intramuscularly injection at pre-defined injection sites

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)	follow-up 48 days after dosing
Secondary	pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax	Maximum measured plasma concentration over the time span specified	follow-up 48 days after dosing
Secondary	pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax	Time of the maximum measured plasma concentration	follow-up 48 days after dosing
Secondary	pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP	Change in C reactive protein levels	on Day 3, 7, 10 and 14