To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2021-06-30

Brief Summary

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

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Detailed Description

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Conditions

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COVID-19 Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 (288mg)

72 mg/0.3 mL x 4 injection sites

Group Type EXPERIMENTAL

DWRX2003

Intervention Type DRUG

Intramuscularly injection at predefined injection sites

Drug: Placebo Intramuscularly injection at predefined injection sites

Cohort 2 (576 mg)

144 mg/0.6 mL x 4 injection sites

Group Type EXPERIMENTAL

DWRX2003

Intervention Type DRUG

Intramuscularly injection at predefined injection sites

Drug: Placebo Intramuscularly injection at predefined injection sites

Cohort 3 (960 mg)

216 mg/1.0 mL x 4 injection sites

Group Type EXPERIMENTAL

DWRX2003

Intervention Type DRUG

Intramuscularly injection at predefined injection sites

Drug: Placebo Intramuscularly injection at predefined injection sites

Interventions

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DWRX2003

Intramuscularly injection at predefined injection sites

Drug: Placebo Intramuscularly injection at predefined injection sites

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes