Acute UrticariaPhase 1NCT02045524
A Pilot Single Dose Crossover Pharmacokinetics Study Of JDP-205 Injection, 10 mg, In Healthy Male And Female Volunteers
A Phase 1 study testing Deep muscle injection and Sub-Q Injection in people with Acute Urticaria, run by JDP Therapeutics, Inc. at 1 site in Canada.
Trial summary
The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205 injection at 10 mg dose administered by intramuscular injection using various injection techniques in healthy male and female volunteers after a single dose administration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Urticaria
- What is being tested?
- Deep muscle injection and Sub-Q Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Sep 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers meeting all of the following criteria were considered for enrollment in the study:
- Male or female volunteer
- Volunteer aged of at least 18 years
- Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
- Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
- Availability for the entire study period
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- Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination (including the examination of the anterolateral thigh muscles) and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
- Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
Who cannot join
- Volunteers presenting any of the following were not included in the study:
- Females who are pregnant or are lactating
- Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study (from the screening visit until study completion)
- History of significant hypersensitivity to cetirizine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
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- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other clinically significant ECG abnormalities
- Known presence of rare hereditary problems of galactose and /or lactose intolerance
- Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
- Use of antihistaminic medication in the previous 7 days before day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive urine screening of ethanol and/or drugs of abuse
- Positive results to HIV, HBsAg or anti-HCV tests
- Females who are pregnant according to a positive serum pregnancy test
- Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205 injection at 10 mg dose administered by intramuscular injection using various injection techniques in healthy male and female volunteers after a single dose administration.
- Conditions
- Acute Urticaria
- Being tested
- Deep muscle injection, Sub-Q Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep muscle injectionOther
Sub-Q InjectionOther
| Study group | Role | What they receive |
|---|---|---|
| Injection location1 | Experimental | Single dose IM injection Receives: Other: Deep muscle injection |
| Injection location 2 | Experimental | Single dose IM Injection Receives: Other: Sub-Q Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pharmacokinetics: Difference in AUC
Measured: 8 hours post dose
Differences in pharmacokinetics: difference in Cmax
Measured: 8 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute UrticariaStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- JDP Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045524
- Sponsor's protocol ID
- ETTAU-01P (CTN-P1-571)
- Status last verified
- Mar 2024
- First submitted
- 22 Jan 2014
- Last updated
- 6 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single Dose Crossover Pharmacokinetics Study Of JDP-205 Injection, 10 mg, In Healthy Male And Female Volunteers
- ClinicalTrials.gov ID
- NCT02045524
- Acronym / sponsor ID
- ETTAU-01P (CTN-P1-571)
- Conditions
- Acute Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- JDP Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jan 2014 (estimated)
- 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.
The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205 injection at 10 mg dose administered by intramuscular injection using various injection techniques in healthy male and female volunteers after a single dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection location1 | Experimental | Other: Deep muscle injectionSingle dose IM injection |
| Injection location 2 | Experimental | Other: Sub-Q InjectionSingle dose IM Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteers meeting all of the following criteria were considered for enrollment in the study:
- Male or female volunteer
- Volunteer aged of at least 18 years
- Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
- Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
Key exclusion criteria (20 listed)
- Females who are pregnant or are lactating
- Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study (from the screening visit until study completion)
- History of significant hypersensitivity to cetirizine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
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 |
|---|---|---|
| Deep muscle injection | Other | Injection location1 |
| Sub-Q Injection | Other | Injection location 2 |
Primary outcome
Difference in pharmacokinetics: Difference in AUC
Time frame: 8 hours post dose
Differences in pharmacokinetics: difference in Cmax
Time frame: 8 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep muscle injection and Sub-Q Injection in people with Acute Urticaria, run by JDP Therapeutics, Inc. at 1 site in Canada.
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 10 inclusion and 20 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in pharmacokinetics: Difference in AUC (time frame: 8 hours post dose). The study lists 2 primary outcomes in all. 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 6 Mar 2024.