NCT04749173

To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers.

A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase I study is a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability and PK profile of single intramuscular doses of DWRX2003 in healthy volunteers.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	DWRX2003, 96mg	Drug: Placebo Intramuscularly injection at predefined injection sites
DRUG	DWRX2003, 432mg	Drug: Placebo Intramuscularly injection at predefined injection sites
DRUG	DWRX2003, 144mg	Drug: Placebo Intramuscularly injection at predefined injection sites
DRUG	DWRX2003, 144mg	Drug: Placebo Intramuscularly injection at predefined injection sites

Timeline

• Start date: 2020-11-21
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2021-02-11
• Last updated: 2021-12-13

Locations

1 site across 1 country: South Korea