HealthyPhase 1NCT04524052
To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19
A Phase 1 study testing DWRX2003 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWRX2003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Dec 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
- Volunteers who agree to give written informed consent and are willing to participate in the study.
- Volunteer having bodyweight minimum of 50 kg.
- Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).
Who cannot join
- Known allergic to Niclosamide or any component of the formulation and to any other related drug.
- History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
- History/ current use of Alcohol or drug abuse.
About this study
Official title: 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
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.
- Conditions
- Healthy
- Being tested
- DWRX2003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWRX2003Drug
Intramuscularly injection at pre-defined injection sites
PlaceboDrug
Intramuscularly injection at pre-defined injection sites
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 (144 mg) | Experimental | Arms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites Receives: Drug: DWRX2003; Drug: Placebo |
| cohort 2 (432 mg) | Experimental | Arms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites Receives: Drug: DWRX2003; Drug: Placebo |
| cohort 3 (960 mg) | Experimental | Arms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites Receives: Drug: DWRX2003; Drug: Placebo |
| cohort 4 (1200 mg) | Experimental | Arms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 sites Receives: Drug: DWRX2003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Measured: follow-up 48 days after dosing
Secondary outcomes (3)
pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax
Maximum measured plasma concentration over the time span specified
Measured: follow-up 48 days after dosing
pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax
Time of the maximum measured plasma concentration
Measured: follow-up 48 days after dosing
pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP
Change in C reactive protein levels
Measured: on Day 3, 7, 10 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524052
- Sponsor's protocol ID
- DWJ1516101_India
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- 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 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04524052
- Acronym / sponsor ID
- DWJ1516101_India
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Aug 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 to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cohort 1 (144 mg) | Experimental | Drug: DWRX2003, Drug: PlaceboArms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites |
| cohort 2 (432 mg) | Experimental | Drug: DWRX2003, Drug: PlaceboArms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites |
| cohort 3 (960 mg) | Experimental | Drug: DWRX2003, Drug: PlaceboArms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites |
| cohort 4 (1200 mg) | Experimental | Drug: DWRX2003, Drug: PlaceboArms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 sites |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
- Volunteers who agree to give written informed consent and are willing to participate in the study.
- Volunteer having bodyweight minimum of 50 kg.
- Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).
Key exclusion criteria (4 listed)
- Known allergic to Niclosamide or any component of the formulation and to any other related drug.
- History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
- History/ current use of Alcohol or drug abuse.
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 pre-defined injection sites | Drug | cohort 1 (144 mg), cohort 2 (432 mg), cohort 3 (960 mg), cohort 4 (1200 mg) |
| PlaceboIntramuscularly injection at pre-defined injection sites | Drug | cohort 1 (144 mg), cohort 2 (432 mg), cohort 3 (960 mg), cohort 4 (1200 mg) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: follow-up 48 days after dosing
AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
3 secondary outcomes
pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax
Time frame: follow-up 48 days after dosing
pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax
Time frame: follow-up 48 days after dosing
pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP
Time frame: on Day 3, 7, 10 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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 Healthy, 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 4 inclusion and 4 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 24 Aug 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 48 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 24 Aug 2020.