To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

COVID-19 Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04592835
• Other study ID #: DW_DWJ1516101_Australia
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 19, 2020
• Est. completion date: June 30, 2021

Study information

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

Clinical Trial Summary

This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 30, 2021
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).

2. Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).

3. Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken

Exclusion Criteria:

1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;

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

3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)

Related Conditions & MeSH terms

• COVID-19 Patients

Intervention

Drug:
• DWRX2003
Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.	Novotech (Australia) Pty Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)	follow-up 35 days after dosing
Secondary	To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax	Measured through Maximum (peak) plasma drug concentration (Cmax)	at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Secondary	To assess PK parameters of niclosamide injectable (DWRX2003) through tmax	Time to reach Cmax following IP administration (tmax)	at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Secondary	To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last	Area under the curve from zero to time of last measurable concentration (AUC0-last)	at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Secondary	To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-8	Area under the curve from zero to infinity (AUC0-8)	at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Secondary	To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2	Elimination half-life (t1/2)	at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28