COVID-19 PatientsPhase 1NCT04592835
To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003
A Phase 1 study testing DWRX2003 in people with COVID-19 Patients, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Patients
- What is being tested?
- DWRX2003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2020to 30 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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
This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.
- Conditions
- COVID-19 Patients
- Being tested
- DWRX2003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWRX2003Drug
Intramuscularly injection at predefined injection sites
Drug: Placebo Intramuscularly injection at predefined injection sites
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (288mg) | Experimental | 72 mg/0.3 mL x 4 injection sites Receives: Drug: DWRX2003 |
| Cohort 2 (576 mg) | Experimental | 144 mg/0.6 mL x 4 injection sites Receives: Drug: DWRX2003 |
| Cohort 3 (960 mg) | Experimental | 216 mg/1.0 mL x 4 injection sites Receives: Drug: DWRX2003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Measured: follow-up 35 days after dosing
Secondary outcomes (5)
To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax
Measured through Maximum (peak) plasma drug concentration (Cmax)
Measured: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through tmax
Time to reach Cmax following IP administration (tmax)
Measured: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
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)
Measured: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞
Area under the curve from zero to infinity (AUC0-∞)
Measured: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2
Elimination half-life (t1/2)
Measured: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Oct 2020 (estimated)
- Primary completion13 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PatientsStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592835
- Sponsor's protocol ID
- DW_DWJ1516101_Australia
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04592835
- Acronym / sponsor ID
- DW_DWJ1516101_Australia
- Conditions
- COVID-19 Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 19 Oct 2020 (estimated)
- Primary completion
- 13 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (288mg) | Experimental | Drug: DWRX200372 mg/0.3 mL x 4 injection sites |
| Cohort 2 (576 mg) | Experimental | Drug: DWRX2003144 mg/0.6 mL x 4 injection sites |
| Cohort 3 (960 mg) | Experimental | Drug: DWRX2003216 mg/1.0 mL x 4 injection sites |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWRX2003Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites | Drug | Cohort 1 (288mg), Cohort 2 (576 mg), Cohort 3 (960 mg) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: follow-up 35 days after dosing
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
5 secondary outcomes
To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through tmax
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWRX2003 in people with COVID-19 Patients, run by Daewoong Pharmaceutical Co. LTD..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: follow-up 35 days after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.