MEDI3902 for Prevention of P. Aeruginosa PneumoniaPhase 1NCT02255760
Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
A Phase 1 study testing MEDI3902 - Dose 1, MEDI3902 - Dose 2 and MEDI3902 - Dose 3 in people with MEDI3902 for Prevention of P. Aeruginosa Pneumonia, run by MedImmune LLC at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- MEDI3902 for Prevention of P. Aeruginosa Pneumonia
- What is being tested?
- MEDI3902 - Dose 1, MEDI3902 - Dose 2 and MEDI3902 - Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2014to 20 Apr 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 through 60 years at the time of screening
- Written informed consent
- Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at screening
- Healthy by medical history, physical examination, and baseline safety laboratory studies
- Systolic blood pressure (BP) less than (<) 140 millimeter of mercury (mmHg) and diastolic BP < 90 mmHg at screening
- Electrocardiogram (ECG) without clinically significant abnormalities at screening
- Able to complete the follow-up period through Day 61 as required by the protocol.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must have used a highly effective method of contraception for at least 28 days prior to dosing with investigational product and must agree to continue using such precautions through Day 61 of the study.
Who cannot join
- Acute (time-limited) illness, including fever 99.5 degree Fahrenheit (0^F), on day prior to or day of planned dosing
- Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine, or combination over-the-counter (OTC) product that contains acetaminophen with an antihistamine, or OTC non-steroidal anti inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, ie, have been taken for at least 30 days prior to enrolment, are not exclusionary
- Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
- Receipt of immunoglobulin or blood products within 6 months prior to screening
- Receipt of any investigational product in the preceding 90 days or expected receipt of investigational product during the period of study follow-up, or concurrent participation in another interventional study Receipt of any vaccine within 7 days prior to investigational product dosing or planned receipt within 61 days after investigational product dosing except for influenza vaccine administered at least 28 days after dosing
- Previous receipt of a mAb
Show all 12Show fewer
- Immunodeficiency due to illness, including human immunodeficiency virus (HIV) infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. HIV testing must be negative at screening
- History of allergic disease or reactions likely to be exacerbated by any component of the investigational product
- Either history of active infection with hepatitis B or C
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above the upper limit of normal (ULN) or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening and in the predose blood sample
- Pregnant or nursing mother
- 13. History of alcohol or drug abuse within the past 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of MEDI3902 in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4 fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 60 day safety follow up period.
- Being tested
- MEDI3902 - Dose 1, MEDI3902 - Dose 2, MEDI3902 - Dose 3, MEDI3902 - Dose 4, Placebo
- Keywords
- MEDI3902, Safety,, Pharmacokinetics,, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI3902 - Dose 1Drug
Also called MEDI3902
Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
MEDI3902 - Dose 2Drug
Also called MEDI3902
Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
MEDI3902 - Dose 3Drug
Also called MEDI3902
Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
MEDI3902 - Dose 4Drug
Also called MEDI3902
Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
PlaceboOther
Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| MEDI3902 - Dose 1 | Experimental | Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. Receives: Drug: MEDI3902 - Dose 1 |
| MEDI3902 - Dose 2 | Experimental | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. Receives: Drug: MEDI3902 - Dose 2 |
| MEDI3902 - Dose 3 | Experimental | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. Receives: Drug: MEDI3902 - Dose 3 |
| MEDI3902 - Dose 4 | Experimental | Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. Receives: Drug: MEDI3902 - Dose 4 |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: Day 1 to Day 29
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)
An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.
Measured: Day 1 to Day 61
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.
Measured: Day 1 to Day 29
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.
Measured: Day 1 to Day 7
Secondary outcomes (6)
Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Measured: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose
The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Measured: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Terminal Phase Elimination Half-life (t1/2)
The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Measured: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Volume of Distribution at Steady State (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Measured: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
MEDI3902 Serum Clearance (CL) of MEDI3902
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Measured: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.
Measured: Days 1 (pre-dose), 15, 29, and 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study start4 Sep 2014
- Primary completion20 Apr 2015
- Study completion20 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MEDI3902 for Prevention of P. Aeruginosa PneumoniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hasan S. Jafri, M.D., Study director, MedImmune LLCMartha Hernandez-Illas, MD, Principal investigator, MRA Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255760
- Sponsor's protocol ID
- D5470C00002
- Status last verified
- Nov 2017
- First submitted
- 16 Sep 2014
- Last updated
- 13 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of MEDI3902 in Healthy Adults
- ClinicalTrials.gov ID
- NCT02255760
- Acronym / sponsor ID
- D5470C00002
- Keywords
- MEDI3902, Safety,, Pharmacokinetics,, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 20 Apr 2015 (actual)
- Study completion
- 20 Apr 2015 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Posted 13 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4 fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 60 day safety follow up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MEDI3902 - Dose 1 | Experimental | Drug: MEDI3902 - Dose 1Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
| MEDI3902 - Dose 2 | Experimental | Drug: MEDI3902 - Dose 2Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
| MEDI3902 - Dose 3 | Experimental | Drug: MEDI3902 - Dose 3Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
| MEDI3902 - Dose 4 | Experimental | Drug: MEDI3902 - Dose 4Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 through 60 years at the time of screening
- Written informed consent
- Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at screening
- Healthy by medical history, physical examination, and baseline safety laboratory studies
- Systolic blood pressure (BP) less than (<) 140 millimeter of mercury (mmHg) and diastolic BP < 90 mmHg at screening
Key exclusion criteria (12 listed)
- Acute (time-limited) illness, including fever 99.5 degree Fahrenheit (0^F), on day prior to or day of planned dosing
- Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine, or combination over-the-counter (OTC) product that contains acetaminophen with an antihistamine, or OTC non-steroidal anti inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, ie, have been taken for at least 30 days prior to enrolment, are not exclusionary
- Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
- Receipt of immunoglobulin or blood products within 6 months prior to screening
- Receipt of any investigational product in the preceding 90 days or expected receipt of investigational product during the period of study follow-up, or concurrent participation in another interventional study Receipt of any vaccine within 7 days prior to investigational product dosing or planned receipt within 61 days after investigational product dosing except for influenza vaccine administered at least 28 days after dosing
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 |
|---|---|---|
| MEDI3902 - Dose 1Also: MEDI3902Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. | Drug | MEDI3902 - Dose 1 |
| MEDI3902 - Dose 2Also: MEDI3902Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. | Drug | MEDI3902 - Dose 2 |
| MEDI3902 - Dose 3Also: MEDI3902Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. | Drug | MEDI3902 - Dose 3 |
| MEDI3902 - Dose 4Also: MEDI3902Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. | Drug | MEDI3902 - Dose 4 |
| PlaceboParticipants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. | Other | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 29
An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)
Time frame: Day 1 to Day 61
An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 29
Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 7
Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.
6 secondary outcomes
Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
Time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose
Time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Terminal Phase Elimination Half-life (t1/2)
Time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Volume of Distribution at Steady State (Vss)
Time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
MEDI3902 Serum Clearance (CL) of MEDI3902
Time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
Time frame: Days 1 (pre-dose), 15, 29, and 61
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Hasan S. Jafri, M.D. study director
MedImmune LLC
Martha Hernandez-Illas, MD principal investigator
MRA Clinical Research, 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 MEDI3902 - Dose 1, MEDI3902 - Dose 2 and MEDI3902 - Dose 3 in people with MEDI3902 for Prevention of P. Aeruginosa Pneumonia, run by MedImmune LLC at 1 site in United States.
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 8 inclusion and 12 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 13 Aug 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1 to Day 29). The study lists 4 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 13 Aug 2018.