Rheumatoid ArthritisPhase 1NCT02800811
Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104
A Phase 1 study testing FR104 in people with Rheumatoid Arthritis and Complication of Transplant, run by OSE Immunotherapeutics at 1 site in Belgium.
Trial summary
First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Complication of Transplant
- What is being tested?
- FR104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting all of the following criteria are eligible to participate in this study:
- Male or female, aged 18 to 60 years, extremes includes;
- In good health condition [medically stable] as determined on the basis of medical history, vital signs, clinical laboratory testing, and general physical examination performed at screening; Note: a retest can be done in case of an out of range clinical laboratory test value that will determine a subject's eligibility. This retest is preferably to be done at an unscheduled visit. The result of the retest are considered for subject eligibility. If the retest is outside normal reference ranges, the subject are eligible for inclusion only if the investigator judges the abnormalities to be not clinically significant.
- Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations, as judged by the investigator; Note: a retest can be done in case of an out of range ECG value that can determine a subject's eligibility.
- Weighs at least 50 kg and no more than 100 kg and has a Body Mass Index (BMI) within normal range: 18.0≤BMI<30.0 kg/m2;
- Negative urine test for selected drugs of abuse at screening;
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- Negative alcohol breath test at screening;
- Female subject is postmenopausal or surgically sterile (having had a hysterectomy, bilateral oophorectomy, or tubal ligation);
- Female subject has a negative pregnancy test at screening;
- Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of an effective method of contraception until 90 days after the last administration of study drug ;
- Male subject has to agree not to donate sperm until 90 days after the last administration of study drug;
- Willing to adhere to the prohibitions and restrictions specified in this protocol;
- Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study;
- Subjects were to be EBV-positive as per positive IgG Epstein-Barr nuclear antigen (EBNA) test;
- Nonsmoker or light smoker, i.e., smokes maximal 5 cigarettes (or 3 cigars or 3 pipe-full) per day, and ability and willingness to refrain from smoking during confinement and ambulant visits in the clinical research center.
- For Part 1, Cohort B only:
- The subject did not undergo a KLH challenge.
Who cannot join
- Subjects meeting one or more of the following criteria are excluded from participation in this study:
- A history of any clinically significant (as determined by the investigator) cardiac, endocrinology, hematology, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer;
- A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its compounds;
- The subject has a history of severe allergic or anaphylactic reactions;
- The subject has a history of consuming more than 21 (14 for females) units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 330 mL of beer, 110 mL of wine or 28 mL of spirits);
- Evidence or history of any clinically significant infections within the past 3 months;
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- History of or evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) diagnosed by a positive QuantiFERON® TB-Gold In Tube test or a positive tuberculin skin test ("Mantoux") in case of a weak positive QuantiFERON® TB-Gold In Tube test;
- Subjects with known clinically relevant immunological disorders, or auto-immune disorders, (e.g., rheumatoid arthritis, lupus erythematosus, scleroderma, etc...);
- Subjects with a recent infection of EBV diagnosed by a positive IgM VCA;
- A positive hepatitis panel (including hepatitis B surface antigen [HBsAg] and anti-hepatitis C virus [HCV] antibodies [Abs]) or positive human immunodeficiency virus (HIV) antibody screens;
- The subject has a supine systolic blood pressure (SBP) <90 or >160 mmHg and a diastolic blood pressure (DBP) <50 or >90 mmHg, or pulse rate higher than 100 bpm, either at screening (blood pressure measurements taken after subject has been resting in a supine position for a minimum of 5 minutes); Note: a retest can be done in case of an out of range vital signs value that will determine a subject's eligibility. The result of the retest are considered for subject eligibility.
- The subject is pregnant or breastfeeding;
- The subject has received a vaccine within 60 days prior to study drug administration;
- The subject has received any systemic immunosuppressant agent within 6 months prior to study drug administration;
- The subject has received any antibody or biologic medicinal product within 6 months prior to study drug administration;
- The subject has received any systemic steroid within 2 months prior to study drug administration;
- Use of a prohibited therapy within 14 days prior to study drug administration;
- Receipt of any investigational drug within 30 days or ten half-lives, whichever is longer, prior to the initial study drug administration;
- The subject is participating in another clinical trial or has participated in another dose group of the current trial;
- Had a significant blood loss (including blood donation [>500 mL]) or having had a transfusion of any blood product within the 60 days or donated plasma within 7 days prior to the initial study drug administration;
- A condition that, in the opinion of the investigator, could compromise the well-being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements.
- Intent to visit regions where tuberculosis and mycosis are endemic during the period of 3 months after dosing (4 months after dosing for subjects in Cohort C) , i.e., deserts areas, Eastern Europe, Central and South America, Africa except Egypt, Russia, Asia, Indonesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy Subjects
First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
Read the detailed description
This study is a first-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
64 healthy male and female subjects are selected according to the inclusion and exclusion criteria, i.e., 50 subjects in Part 1 (SAD: 2 cohorts of 22 [Cohort A], 28 [Cohort B], respectively) and 14 subjects in Part 2 (MAD). The total duration of the study is 10 months.
All FR104 doses are administered intravenously by a slow infusion of at least 30 minutes. A staggered approach is observed within all dose levels. An interval of at least 14 days (last to first administration) is observed between all dose levels. Individual subjects on a same day of dosing are dosed at least 60 minutes apart.
- Conditions
- Rheumatoid Arthritis, Complication of Transplant
- Being tested
- FR104, Placebo
- Keywords
- FR104, CD28, immunomodulation, T regulatory cell, Pegylated monovalent anti-CD28 Fab antibody
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FR104Drug
GMP FR104 is provided to the site in extractable volume vials containing FR104. Appropriate Dilutions in Ringer's lactate solution is made on site.
PlaceboDrug
The placebo injection contains the vehicle. For placebo dosing, vehicle is administered in accordance with the volume of study drug administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort A, Group 1, FR104 | Experimental | Dose: single 0.005 mg/kg. Receives: Drug: FR104 |
| Part 1: Cohort A, Group 2, FR104 | Experimental | Dose: single 0.05 mg/kg. Receives: Drug: FR104 |
| Part 1: Cohort A, Group 3, FR104 | Experimental | Dose: single 0.2 mg/kg. Receives: Drug: FR104 |
| Part 1: Cohort A, Group 4, FR104 | Experimental | Dose: single 0.5 mg/kg. Receives: Drug: FR104 |
| Part 1: Cohort A, placebo | Placebo comparator | Placebo, single administration, double blind (1/4 healthy subject in group 1, 1/4 in group 2, 2/5 in group 3 and 2/5 in group 4). Receives: Drug: Placebo |
| Part 1: Cohort B, Group 7, FR104 | Experimental | Dose: single 0.5 mg/kg. Healthy subject naïve to KLH and that will receive a KLH challenge. Receives: Drug: FR104 |
| Part 1: Cohort B, Group 8, FR104 | Experimental | Dose: single 0.2 mg/kg. Healthy subject naïve to KLH and that will receive a KLH challenge. Receives: Drug: FR104 |
| Part 1: Cohort B, Group 9, FR104 | Experimental | Dose: single 1.5 mg/kg. Healthy subject naïve to KLH and that will receive a KLH challenge. Receives: Drug: FR104 |
| Part 1: Cohort B, Group 9 bis, FR104 | Experimental | Dose: single 0.02 mg/kg group. Healthy subject naïve to KLH and that will receive a KLH challenge. Receives: Drug: FR104 |
| Part 1: Cohort B, placebo | Placebo comparator | placebo, single administration, double-blind: healthy subjects naïve to KLH and that will receive a KLH challenge (2/5 in each group of cohort B) Receives: Drug: Placebo |
| Part 2: Group 10, FR104 | Experimental | Dose: repeat, 0.2 mg/kg. Two administrations separated by an interval of 28 days. Receives: Drug: FR104 |
| Part 2: Group 11, FR104 | Experimental | Dose: repeat, 0.5 mg/kg. Two administrations separated by an interval of 28 days. Receives: Drug: FR104 |
| Part 2: placebo | Placebo comparator | placebo, repeat, double-blind: 2/5 subjects in each group of Part 2. Two administrations separated by an interval of 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters in healthy volunteers of FR104 compared to placebo after single (SAD) and two IV doses (MAD).
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Measured: 4 months
Secondary outcomes (5)
Area under the concentration time curve to last quantifiable concentration [AUC (0-T)] after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Measured: 4 months
Terminal half-life (T1/2) of FR104 after single and two repeat iv administrations
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Measured: 4 months
Durations of 100%, 50% and 20% CD28 receptor blocade after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Measured: 4 months
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Measured: 4 months
Type, incidence, severity, timing, seriousness and relatedness of abnormal cytokine levels after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSE Immunotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Ramael, Principal investigator, SGS Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800811
- Sponsor's protocol ID
- FR104-CT01
- Other IDs
- 2015-000302-19, 2015
- Status last verified
- Jul 2016
- First submitted
- 20 May 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02800811
- Acronym / sponsor ID
- FR104-CT01
- Conditions
- Rheumatoid Arthritis, Complication of Transplant
- Keywords
- FR104, CD28, immunomodulation, T regulatory cell, Pegylated monovalent anti-CD28 Fab antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- OSE ImmunotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jun 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.
First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
Detailed description
This study is a first-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
64 healthy male and female subjects are selected according to the inclusion and exclusion criteria, i.e., 50 subjects in Part 1 (SAD: 2 cohorts of 22 [Cohort A], 28 [Cohort B], respectively) and 14 subjects in Part 2 (MAD). The total duration of the study is 10 months.
All FR104 doses are administered intravenously by a slow infusion of at least 30 minutes. A staggered approach is observed within all dose levels. An interval of at least 14 days (last to first administration) is observed between all dose levels. Individual subjects on a same day of dosing are dosed at least 60 minutes apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort A, Group 1, FR104 | Experimental | Drug: FR104Dose: single 0.005 mg/kg. |
| Part 1: Cohort A, Group 2, FR104 | Experimental | Drug: FR104Dose: single 0.05 mg/kg. |
| Part 1: Cohort A, Group 3, FR104 | Experimental | Drug: FR104Dose: single 0.2 mg/kg. |
| Part 1: Cohort A, Group 4, FR104 | Experimental | Drug: FR104Dose: single 0.5 mg/kg. |
| Part 1: Cohort A, placebo | Placebo comparator | Drug: PlaceboPlacebo, single administration, double blind (1/4 healthy subject in group 1, 1/4 in group 2, 2/5 in group 3 and 2/5 in group 4). |
| Part 1: Cohort B, Group 7, FR104 | Experimental | Drug: FR104Dose: single 0.5 mg/kg. Healthy subject naïve to KLH and that will receive a KLH challenge. |
| Part 1: Cohort B, Group 8, FR104 | Experimental | Drug: FR104Dose: single 0.2 mg/kg. Healthy subject naïve to KLH and that will receive a KLH challenge. |
| Part 1: Cohort B, Group 9, FR104 | Experimental | Drug: FR104Dose: single 1.5 mg/kg. Healthy subject naïve to KLH and that will receive a KLH challenge. |
| Part 1: Cohort B, Group 9 bis, FR104 | Experimental | Drug: FR104Dose: single 0.02 mg/kg group. Healthy subject naïve to KLH and that will receive a KLH challenge. |
| Part 1: Cohort B, placebo | Placebo comparator | Drug: Placeboplacebo, single administration, double-blind: healthy subjects naïve to KLH and that will receive a KLH challenge (2/5 in each group of cohort B) |
| Part 2: Group 10, FR104 | Experimental | Drug: FR104Dose: repeat, 0.2 mg/kg. Two administrations separated by an interval of 28 days. |
| Part 2: Group 11, FR104 | Experimental | Drug: FR104Dose: repeat, 0.5 mg/kg. Two administrations separated by an interval of 28 days. |
| Part 2: placebo | Placebo comparator | Drug: Placeboplacebo, repeat, double-blind: 2/5 subjects in each group of Part 2. Two administrations separated by an interval of 28 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male or female, aged 18 to 60 years, extremes includes;
- In good health condition [medically stable] as determined on the basis of medical history, vital signs, clinical laboratory testing, and general physical examination performed at screening; Note: a retest can be done in case of an out of range clinical laboratory test value that will determine a subject's eligibility. This retest is preferably to be done at an unscheduled visit. The result of the retest are considered for subject eligibility. If the retest is outside normal reference ranges, the subject are eligible for inclusion only if the investigator judges the abnormalities to be not clinically significant.
- Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations, as judged by the investigator; Note: a retest can be done in case of an out of range ECG value that can determine a subject's eligibility.
- Weighs at least 50 kg and no more than 100 kg and has a Body Mass Index (BMI) within normal range: 18.0≤BMI<30.0 kg/m2;
- Negative urine test for selected drugs of abuse at screening;
Key exclusion criteria (22 listed)
- Subjects meeting one or more of the following criteria are excluded from participation in this study:
- A history of any clinically significant (as determined by the investigator) cardiac, endocrinology, hematology, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer;
- A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its compounds;
- The subject has a history of severe allergic or anaphylactic reactions;
- The subject has a history of consuming more than 21 (14 for females) units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 330 mL of beer, 110 mL of wine or 28 mL of spirits);
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 |
|---|---|---|
| FR104GMP FR104 is provided to the site in extractable volume vials containing FR104. Appropriate Dilutions in Ringer's lactate solution is made on site. | Drug | Part 1: Cohort A, Group 1, FR104, Part 1: Cohort A, Group 2, FR104, Part 1: Cohort A, Group 3, FR104, Part 1: Cohort A, Group 4, FR104, Part 1: Cohort B, Group 7, FR104, Part 1: Cohort B, Group 8, FR104, Part 1: Cohort B, Group 9 bis, FR104, Part 1: Cohort B, Group 9, FR104, Part 2: Group 10, FR104, Part 2: Group 11, FR104 |
| PlaceboThe placebo injection contains the vehicle. For placebo dosing, vehicle is administered in accordance with the volume of study drug administered. | Drug | Part 1: Cohort A, placebo, Part 1: Cohort B, placebo, Part 2: placebo |
Primary outcome
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters in healthy volunteers of FR104 compared to placebo after single (SAD) and two IV doses (MAD).
Time frame: 4 months
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
5 secondary outcomes
Area under the concentration time curve to last quantifiable concentration [AUC (0-T)] after single and two repeat iv administrations of FR104
Time frame: 4 months
Terminal half-life (T1/2) of FR104 after single and two repeat iv administrations
Time frame: 4 months
Durations of 100%, 50% and 20% CD28 receptor blocade after single and two repeat iv administrations of FR104
Time frame: 4 months
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) after single and two repeat iv administrations of FR104
Time frame: 4 months
Type, incidence, severity, timing, seriousness and relatedness of abnormal cytokine levels after single and two repeat iv administrations of FR104
Time frame: 4 months
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 21 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Steven Ramael principal investigator
SGS Antwerpen
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 FR104 in people with Rheumatoid Arthritis and Complication of Transplant, run by OSE Immunotherapeutics 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 17 inclusion and 22 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 21 Jul 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. 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?
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters in healthy volunteers of FR104 compared to placebo after single (SAD) and two IV doses (MAD). (time frame: 4 months). 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 21 Jul 2016.