To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

NCT04592835 | Unknown Phase 1 DMC

• 1 other identifier: DW_DWJ1516101_Australia
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

COVID-19 Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax

  at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28

• To assess PK parameters of niclosamide injectable (DWRX2003) through tmax

  at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28

• To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last

  at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28

• To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞

  at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28

• To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2

  at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28

Study Arms (3)

Cohort 1 (288mg)

EXPERIMENTAL

72 mg/0.3 mL x 4 injection sites

Drug: DWRX2003

Cohort 2 (576 mg)

EXPERIMENTAL

144 mg/0.6 mL x 4 injection sites

Drug: DWRX2003

Cohort 3 (960 mg)

EXPERIMENTAL

216 mg/1.0 mL x 4 injection sites

Drug: DWRX2003

Interventions

DWRX2003 DRUG

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

Cohort 1 (288mg); Cohort 2 (576 mg); Cohort 3 (960 mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: October 19, 2020
• Primary Completion: December 13, 2020
• Study Completion: June 30, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share