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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04524052

Enrollment

Registered

2020-08-24

Start date

2020-08-31

Completion date

2020-12-31

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGDWRX2003

Intramuscularly injection at pre-defined injection sites

DRUGPlacebo

Intramuscularly injection at pre-defined injection sites

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events	follow-up 48 days after dosing	AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

Secondary

Measure	Time frame	Description
pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax	follow-up 48 days after dosing	Maximum measured plasma concentration over the time span specified
pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax	follow-up 48 days after dosing	Time of the maximum measured plasma concentration
pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP	on Day 3, 7, 10 and 14	Change in C reactive protein levels

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026