HealthyPhase 1NCT01840501
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42721458 in Healthy Male Participants
A Phase 1 study testing JNJ-42721458 (single dose) and JNJ-42721458 (multiple doses) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication), potential immunogenicity (ability to induce an immune response), and pharmacodynamics (what the drug does to the body) after administration of JNJ-42721458 in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42721458 (single dose) and JNJ-42721458 (multiple doses)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Apr 2014
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (weight kg/m2) between 18 and 30 kg/m2, and body weight not less than 50 kg
- Participant is judged to be generally in good health based on medical history, physical examination, vital signs and laboratory safety tests
- Blood pressure between 90 and 135 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram consistent with normal cardiac conduction and function
Who cannot join
- History of or current clinically significant medical illness
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or on Day -1 (at admission to the study center)
- Estimated creatinine clearance of less than or equal to 80 mL/min
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or on Day -1
- Participant demonstrates orthostatic change in vital signs measurements on screening or predose while going from a semi recumbent to standing position
- History of significant multiple and/or severe allergies (including latex allergies) or known history of clinically significant allergies to polyethylene glycol (PEG) containing or other PEGylated products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single- and Multiple-Doses of JNJ-42721458 in Healthy Male Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication), potential immunogenicity (ability to induce an immune response), and pharmacodynamics (what the drug does to the body) after administration of JNJ-42721458 in healthy adult male participants.
Read the detailed description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), single-ascending (increasing) dose and multiple-ascending dose study of JNJ-42721458 compound in healthy males. The study is divided in two parts. Part 1 is a single-ascending dose (SAD) study which will include up to 10 panels (using ascending doses starting from 0.1 mg) in which a single dose of the study medication will be administered on Day 1. Part 2 is a multiple-ascending dose (MAD) study which will include approximately 6 panels (using ascending doses starting from 5.0 mg) in which multiple doses of study medication will be administered once daily for 10 days.
Part 2 will be initiated after completion of dosing and all relevant evaluations from Part 1. In each panel of Part 1 and 2, 6 participants will be randomly assigned to receive JNJ-42721458 and 2 participants randomly assigned to placebo. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests, vital signs, electrocardiograms, cardiac telemetry and evaluation of injection sites which will be monitored throughout the study. The total study duration for each participant will be approximately 6-7 weeks in Part 1 and 7-8 weeks for each participant in Part 2.
- Conditions
- Healthy
- Being tested
- JNJ-42721458 (single dose), JNJ-42721458 (multiple doses), Placebo (single dose), Placebo (multiple doses)
- Keywords
- Healthy, JNJ-42721458, Male, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42721458 (single dose)Drug
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.
JNJ-42721458 (multiple doses)Drug
JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.
Placebo (single dose)Drug
Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1.
Placebo (multiple doses)Drug
Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Panel 1 (0.1 mg JNJ-42721458) | Experimental | 6 participants will receive a single dose of 0.1 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 2 (0.3 mg JNJ-42721458) | Experimental | 6 participants will receive a single dose of 0.3 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 3 (1.0 mg JNJ-42721458) | Experimental | 6 participants will receive a single dose of 1.0 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 4 (2.5 mg JNJ-42721458) | Experimental | 6 participants will receive a single dose of 2.5 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 5 (5.0 mg JNJ-42721458) | Experimental | 6 participants will receive a single dose of 5.0 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 6 (10.0 mg JNJ-42721458) | Experimental | 6 participants will receive a single dose of 10.0 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 7 (20.0 mg JNJ-42721458) | Experimental | 6 participants will receive a single dose of 20.0 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 8 | Experimental | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-7 in Part 1. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 9 | Experimental | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-8 in Part 1. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Panel 10 | Experimental | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-9 in Part 1. Receives: Drug: JNJ-42721458 (single dose) |
| Part 1: Placebo | Placebo comparator | 2 participants from each panel will receive a single dose of placebo. Receives: Drug: Placebo (single dose) |
| Part 2: Panel 1 (5.0 mg JNJ-42721458) | Experimental | 6 participants will receive multiple doses of 5.0 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (multiple doses) |
| Part 2: Panel 2 (10.0 mg JNJ-42721458) | Experimental | 6 participants will receive multiple doses of 10.0 mg of JNJ-42721458. Receives: Drug: JNJ-42721458 (multiple doses) |
| Part 2: Panel 3 | Experimental | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-2 in Part 2. Receives: Drug: JNJ-42721458 (multiple doses) |
| Part 2: Panel 4 | Experimental | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-3 in Part 2. Receives: Drug: JNJ-42721458 (multiple doses) |
| Part 2: Panel 5 | Experimental | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-4 in Part 2. Receives: Drug: JNJ-42721458 (multiple doses) |
| Part 2: Panel 6 | Experimental | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-5 in Part 2. Receives: Drug: JNJ-42721458 (multiple doses) |
| Part 2: Placebo | Placebo comparator | 2 participants from each panel will receive multiple doses of placebo. Receives: Drug: Placebo (multiple doses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and 2: Number of participants with adverse events
Number of participants with adverse events will be used as a measure of safety and tolerability.
Measured: Up to 17 weeks
Part 1 and 2: Maximum observed concentration (Cmax) of JNJ-42721458
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Time to reach the maximum plasma concentration (tmax) of JNJ-42721458
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Area under the concentration-time curve of JNJ-42721458, from time 0 to infinity, with extrapolation of the terminal phase
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Area under the concentration-time curve of JNJ-42721458 during a dosing interval at steady state
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Terminal half-life (t1/2) of JNJ-42721458
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Apparent systemic clearance of drug after subcutaneous administration of JNJ-42721458
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Apparent volume of distribution after subcutaneous administration of JNJ-42721458
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Plasma levels of antibodies to JNJ-42721458 for evaluation of potential immunogenicity
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Secondary outcomes (2)
Part 1 and 2: Change from baseline in resting heart rate
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Change from baseline in resting peripheral blood pressure
Measured: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
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 Janssen Research & Development, LLCThe 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840501
- Sponsor's protocol ID
- CR101337
- Other IDs
- 42721458EDI1001, 2013-000557-47
- Status last verified
- May 2014
- First submitted
- 23 Apr 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single- and Multiple-Doses of JNJ-42721458 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01840501
- Acronym / sponsor ID
- CR101337
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-42721458, Male, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Apr 2013 (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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication), potential immunogenicity (ability to induce an immune response), and pharmacodynamics (what the drug does to the body) after administration of JNJ-42721458 in healthy adult male participants.
Detailed description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), single-ascending (increasing) dose and multiple-ascending dose study of JNJ-42721458 compound in healthy males. The study is divided in two parts. Part 1 is a single-ascending dose (SAD) study which will include up to 10 panels (using ascending doses starting from 0.1 mg) in which a single dose of the study medication will be administered on Day 1. Part 2 is a multiple-ascending dose (MAD) study which will include approximately 6 panels (using ascending doses starting from 5.0 mg) in which multiple doses of study medication will be administered once daily for 10 days.
Part 2 will be initiated after completion of dosing and all relevant evaluations from Part 1. In each panel of Part 1 and 2, 6 participants will be randomly assigned to receive JNJ-42721458 and 2 participants randomly assigned to placebo. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests, vital signs, electrocardiograms, cardiac telemetry and evaluation of injection sites which will be monitored throughout the study. The total study duration for each participant will be approximately 6-7 weeks in Part 1 and 7-8 weeks for each participant in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Part 1: Panel 1 (0.1 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose of 0.1 mg of JNJ-42721458. |
| Part 1: Panel 2 (0.3 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose of 0.3 mg of JNJ-42721458. |
| Part 1: Panel 3 (1.0 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose of 1.0 mg of JNJ-42721458. |
| Part 1: Panel 4 (2.5 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose of 2.5 mg of JNJ-42721458. |
| Part 1: Panel 5 (5.0 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose of 5.0 mg of JNJ-42721458. |
| Part 1: Panel 6 (10.0 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose of 10.0 mg of JNJ-42721458. |
| Part 1: Panel 7 (20.0 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose of 20.0 mg of JNJ-42721458. |
| Part 1: Panel 8 | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-7 in Part 1. |
| Part 1: Panel 9 | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-8 in Part 1. |
| Part 1: Panel 10 | Experimental | Drug: JNJ-42721458 (single dose)6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-9 in Part 1. |
| Part 1: Placebo | Placebo comparator | Drug: Placebo (single dose)2 participants from each panel will receive a single dose of placebo. |
| Part 2: Panel 1 (5.0 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (multiple doses)6 participants will receive multiple doses of 5.0 mg of JNJ-42721458. |
| Part 2: Panel 2 (10.0 mg JNJ-42721458) | Experimental | Drug: JNJ-42721458 (multiple doses)6 participants will receive multiple doses of 10.0 mg of JNJ-42721458. |
| Part 2: Panel 3 | Experimental | Drug: JNJ-42721458 (multiple doses)6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-2 in Part 2. |
| Part 2: Panel 4 | Experimental | Drug: JNJ-42721458 (multiple doses)6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-3 in Part 2. |
| Part 2: Panel 5 | Experimental | Drug: JNJ-42721458 (multiple doses)6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-4 in Part 2. |
| Part 2: Panel 6 | Experimental | Drug: JNJ-42721458 (multiple doses)6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-5 in Part 2. |
| Part 2: Placebo | Placebo comparator | Drug: Placebo (multiple doses)2 participants from each panel will receive multiple doses of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (weight kg/m2) between 18 and 30 kg/m2, and body weight not less than 50 kg
- Participant is judged to be generally in good health based on medical history, physical examination, vital signs and laboratory safety tests
- Blood pressure between 90 and 135 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram consistent with normal cardiac conduction and function
Key exclusion criteria (6 listed)
- History of or current clinically significant medical illness
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or on Day -1 (at admission to the study center)
- Estimated creatinine clearance of less than or equal to 80 mL/min
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or on Day -1
- Participant demonstrates orthostatic change in vital signs measurements on screening or predose while going from a semi recumbent to standing position
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 |
|---|---|---|
| JNJ-42721458 (single dose)JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg. | Drug | Part 1: Panel 1 (0.1 mg JNJ-42721458), Part 1: Panel 10, Part 1: Panel 2 (0.3 mg JNJ-42721458), Part 1: Panel 3 (1.0 mg JNJ-42721458), Part 1: Panel 4 (2.5 mg JNJ-42721458), Part 1: Panel 5 (5.0 mg JNJ-42721458), Part 1: Panel 6 (10.0 mg JNJ-42721458), Part 1: Panel 7 (20.0 mg JNJ-42721458), Part 1: Panel 8, Part 1: Panel 9 |
| JNJ-42721458 (multiple doses)JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg. | Drug | Part 2: Panel 1 (5.0 mg JNJ-42721458), Part 2: Panel 2 (10.0 mg JNJ-42721458), Part 2: Panel 3, Part 2: Panel 4, Part 2: Panel 5, Part 2: Panel 6 |
| Placebo (single dose)Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1. | Drug | Part 1: Placebo |
| Placebo (multiple doses)Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2. | Drug | Part 2: Placebo |
Primary outcome
Part 1 and 2: Number of participants with adverse events
Time frame: Up to 17 weeks
Number of participants with adverse events will be used as a measure of safety and tolerability.
Part 1 and 2: Maximum observed concentration (Cmax) of JNJ-42721458
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Time to reach the maximum plasma concentration (tmax) of JNJ-42721458
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Area under the concentration-time curve of JNJ-42721458, from time 0 to infinity, with extrapolation of the terminal phase
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Area under the concentration-time curve of JNJ-42721458 during a dosing interval at steady state
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Terminal half-life (t1/2) of JNJ-42721458
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Apparent systemic clearance of drug after subcutaneous administration of JNJ-42721458
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Apparent volume of distribution after subcutaneous administration of JNJ-42721458
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Plasma levels of antibodies to JNJ-42721458 for evaluation of potential immunogenicity
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
2 secondary outcomes
Part 1 and 2: Change from baseline in resting heart rate
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
Part 1 and 2: Change from baseline in resting peripheral blood pressure
Time frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2)
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 May 2014.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 JNJ-42721458 (single dose) and JNJ-42721458 (multiple doses) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 6 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 May 2014. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Part 1 and 2: Number of participants with adverse events (time frame: Up to 17 weeks). The study lists 9 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 May 2014.