HealthyPhase 1NCT02711462
Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234
A Phase 1 study testing PF-06687234 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06687234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2016to Aug 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females of non childbearing potential and healthy males
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Ability to personally sign and date the informed consent document and able to comply with schedule of activities
- For Single Dose Cohort 7 only, Japanese subjects must have four biological Japanese grandparents born in Japan.
Who cannot join
- Evidence or history of clinically significant health concerns
- Treatment with an investigational drug within 30 days
- Exposure to any live vaccines within 28 days prior to investigational product administration.
- History of drug and/ or alcohol abuse and tobacco use equivalent of 5 cigarettes per day.
- Known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
- Pregnant female subjects
- History of sensitivity to heparin
- Unwilling or unable to comply with the Lifestyle Guidelines as stated in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double Blind, Third-Party Open, Randomized, Placebo Controlled, Single And Multiple Dose, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06687234 In Healthy Subjects
This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7 cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are anticipated in the Multiple Dose (MD) portion of the study.
Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety and tolerability. FDA review and agreement to move forward will take place before the remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.
A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two doses).
- Conditions
- Healthy
- Being tested
- PF-06687234, Placebo
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06687234Drug
Also called Dekavil
PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
PlaceboDrug
In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Subjects will receive 2mg of PF 06687234 or placebo via the SC route Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 2 | Other | Subjects will receive 20mg PF 06687234 or placebo via the SC route Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 3 | Other | This is an optional cohort that may be added anytime during the study. In this cohort, subjects will receive PF 06687234 or placebo via the SC route Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 4 | Other | Subjects will receive 40mg of PF 06687234 or placebo via the SC route Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 5 | Other | Subjects will receive 80mg of PF 06687234 or placebo via the SC route Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 6 | Other | Subjects receive a single dose of PF 06687234 or placebo via the IV route Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 7 | Other | This is an optional cohort where Japanese subjects will receive PF 06687234 or placebo via the SC route Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 8 | Other | Subjects in this cohort may receive 20 mg of PF 06687234 or placebo via the SC route every week with a total of 5 doses Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 9 | Other | Subjects in this cohort may receive 40 mg of PF 06687234 or placebo via the SC route every two weeks with a total of 3 doses Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 10 | Other | This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts Receives: Drug: PF-06687234; Drug: Placebo |
| Cohort 11 | Other | This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts Receives: Drug: PF-06687234; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
To determine the safety and tolerability of PF 06687234 by assessing averse events, vital signs measurements, 12 lead ECGs, physical examination findings, blood and urine safety tests including ferritin, transferrin, serum iron, reticulocytes, hemoglobin, platelets and any abnormal laboratory results.
Measured: 4 weeks in the single dose portion and 8 weeks in the multiple dose portion
Secondary outcomes (12)
Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (IV and SC single doses)
Measured: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (SC multiple doses)
Measured: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (IV and SC single doses)
Measured: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (SC multiple doses)
Measured: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (IV and SC single doses)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (SC multiple doses)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (IV and SC single doses)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (SC multiple doses)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast
Measured: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Plasma Decay Half-Life (t1/2) of PF 06687234 (IV and SC single doses)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Plasma Decay Half-Life (t1/2) of PF 06687234 (SC multiple doses)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Incidence of development of anti-drug antibody (ADA)
Measured: up to 2 months
Incidence of development of neutralizing antibody (NAb)
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: The study was prematurely terminated on 06 October 2016 due to the potential risk of further dosing in healthy subjects
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 PfizerThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, PfizerLaure Mendes da Costa, Principal investigator, Pfizer Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711462
- Sponsor's protocol ID
- B7581001
- Other IDs
- 2015-000710-22, DEKAVIL, 2015
- Status last verified
- Nov 2016
- First submitted
- 8 Jan 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double Blind, Third-Party Open, Randomized, Placebo Controlled, Single And Multiple Dose, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06687234 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT02711462
- Acronym / sponsor ID
- B7581001
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated on 06 October 2016 due to the potential risk of further dosing in healthy subjects
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Mar 2016 (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.
This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7 cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are anticipated in the Multiple Dose (MD) portion of the study.
Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety and tolerability. FDA review and agreement to move forward will take place before the remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.
A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two doses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: PF-06687234, Drug: PlaceboSubjects will receive 2mg of PF 06687234 or placebo via the SC route |
| Cohort 2 | Other | Drug: PF-06687234, Drug: PlaceboSubjects will receive 20mg PF 06687234 or placebo via the SC route |
| Cohort 3 | Other | Drug: PF-06687234, Drug: PlaceboThis is an optional cohort that may be added anytime during the study. In this cohort, subjects will receive PF 06687234 or placebo via the SC route |
| Cohort 4 | Other | Drug: PF-06687234, Drug: PlaceboSubjects will receive 40mg of PF 06687234 or placebo via the SC route |
| Cohort 5 | Other | Drug: PF-06687234, Drug: PlaceboSubjects will receive 80mg of PF 06687234 or placebo via the SC route |
| Cohort 6 | Other | Drug: PF-06687234, Drug: PlaceboSubjects receive a single dose of PF 06687234 or placebo via the IV route |
| Cohort 7 | Other | Drug: PF-06687234, Drug: PlaceboThis is an optional cohort where Japanese subjects will receive PF 06687234 or placebo via the SC route |
| Cohort 8 | Other | Drug: PF-06687234, Drug: PlaceboSubjects in this cohort may receive 20 mg of PF 06687234 or placebo via the SC route every week with a total of 5 doses |
| Cohort 9 | Other | Drug: PF-06687234, Drug: PlaceboSubjects in this cohort may receive 40 mg of PF 06687234 or placebo via the SC route every two weeks with a total of 3 doses |
| Cohort 10 | Other | Drug: PF-06687234, Drug: PlaceboThis is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts |
| Cohort 11 | Other | Drug: PF-06687234, Drug: PlaceboThis is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy females of non childbearing potential and healthy males
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Ability to personally sign and date the informed consent document and able to comply with schedule of activities
- For Single Dose Cohort 7 only, Japanese subjects must have four biological Japanese grandparents born in Japan.
Key exclusion criteria (8 listed)
- Evidence or history of clinically significant health concerns
- Treatment with an investigational drug within 30 days
- Exposure to any live vaccines within 28 days prior to investigational product administration.
- History of drug and/ or alcohol abuse and tobacco use equivalent of 5 cigarettes per day.
- Known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
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 |
|---|---|---|
| PF-06687234Also: DekavilPF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses | Drug | Cohort 1, Cohort 10, Cohort 11, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
| PlaceboIn Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo. | Drug | Cohort 1, Cohort 10, Cohort 11, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: 4 weeks in the single dose portion and 8 weeks in the multiple dose portion
To determine the safety and tolerability of PF 06687234 by assessing averse events, vital signs measurements, 12 lead ECGs, physical examination findings, blood and urine safety tests including ferritin, transferrin, serum iron, reticulocytes, hemoglobin, platelets and any abnormal laboratory results.
12 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (IV and SC single doses)
Time frame: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (SC multiple doses)
Time frame: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (IV and SC single doses)
Time frame: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (SC multiple doses)
Time frame: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (IV and SC single doses)
Time frame: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (SC multiple doses)
Time frame: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (IV and SC single doses)
Time frame: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (SC multiple doses)
Time frame: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Plasma Decay Half-Life (t1/2) of PF 06687234 (IV and SC single doses)
Time frame: Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Plasma Decay Half-Life (t1/2) of PF 06687234 (SC multiple doses)
Time frame: Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Incidence of development of anti-drug antibody (ADA)
Time frame: up to 2 months
Incidence of development of neutralizing antibody (NAb)
Time frame: up to 2 months
Results and safety
The study was stopped early (reason given: The study was prematurely terminated on 06 October 2016 due to the potential risk of further dosing in healthy subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Laure Mendes da Costa principal investigator
Pfizer Clinical Research Unit
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 PF-06687234 in people with Healthy, run by Pfizer 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 8 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: stopped early, as of the sponsor's last update on 7 Nov 2016. 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. 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 was stopped early (reason given: The study was prematurely terminated on 06 October 2016 due to the potential risk of further dosing in healthy subjects). 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?
Number of Participants with Adverse Events (AEs) (time frame: 4 weeks in the single dose portion and 8 weeks in the multiple dose portion). 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 7 Nov 2016.