Healthy AdultsPhase 1NCT02388347
A Study to Assess the Safety of MEDI7836 in Healthy Adults.
A Phase 1 study testing MEDI7836 Dose 1, MEDI7836 Dose 2 and MEDI7836 Dose 3 in people with Healthy Adults, run by MedImmune LLC at 1 site in United Kingdom.
Trial summary
To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects and healthy adult female subjects of non-childbearing potential. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- MEDI7836 Dose 1, MEDI7836 Dose 2 and MEDI7836 Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Apr 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Vital signs, ECG, and laboratory parameters within normal range at screening and Day -1
- Negative alcohol and drug screen at screening and Day -1
- Able and willing to comply with the requirements of the protocol
- Females subjects must have been surgically sterilised or be postmenopausal
- Nonsterilised males who are sexually active with a female partner of childbearing potential or a female partner who has been surgically sterilised by bilateral tubal ligation must use a condom with spermicide with their partner from screening until the end of the study follow-up period
Who cannot join
- Concurrent enrolment in another clinical study where the subject is receiving an investigational product
- Individuals who are legally institutionalised
- Receipt of any marketed or investigational biologic agent within 4 months
- Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
- Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half-lives of Day 1,
- Known history of allergy or reaction to any component of the investigational product formulation
Show all 24Show fewer
- History of anaphylaxis following any biologic therapy
- History of chronic alcohol or drug abuse within 12 months prior to screening,
- Presence of a positive drug or alcohol screen at screening and Day -1.
- Current smoker, or history of smoking within 6 months of screening
- Pregnant or breastfeeding women
- Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study
- Any clinically relevant abnormal findings in physical examination, ECG, vital signs, haematology, clinical chemistry or urinalysis during screening or Day -1,
- History of any known primary immunodeficiency disorder or use of immunosuppressive medication within 12 months of screening
- History of a clinically significant infection requiring antibiotics or antiviral medication from 30 days prior to screening, up to and including Day 1
- Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy
- History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening
- Positive tuberculosis (TB) test (Quantiferon-TB Gold) at screening or TB requiring treatment within the 12 months prior to the screening visit
- Positive hepatitis B surface antigen, hepatitis B anti-core antibody, or hepatitis C virus antibody serology at screening.
- Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enter the study.
- A positive human immunodeficiency virus test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report
- Evidence of active liver disease, including jaundice or aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN)
- Major surgery within 8 weeks prior to screening, or planed in-patient surgery or hospitalisation during the study period
- Receipt of live attenuated vaccines 30 days prior to the date of screening Where participation in the study would result in donation of blood or blood products in excess of 500 mL within an 8-week period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a, Randomised, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI7836 in Healthy Adults
To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects and healthy adult female subjects of non-childbearing potential.
Read the detailed description
This is a Phase 1a, randomised, blinded (the investigator and subject will be blinded to treatment assignment and sponsor will be unblinded to treatment assignment), placebo-controlled study to evaluate the safety of single-ascending SC doses of MEDI7836 in healthy adult males subjects and healthy adult female subjects of non-childbearing potential. The study will be conducted at a single site in the United Kingdom (UK). Four dosing cohorts of MEDI7836 or placebo are planned for this study for a total of 32 subjects (24 subjects receiving MEDI7836, 8 subjects receiving placebo).
- Conditions
- Healthy Adults
- Being tested
- Placebo SC, MEDI7836 Dose 1, MEDI7836 Dose 2, MEDI7836 Dose 3, MEDI7836 Dose 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo SCDrug
Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.
MEDI7836 Dose 1Biological
Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.
MEDI7836 Dose 2Biological
Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.
MEDI7836 Dose 3Biological
Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.
MEDI7836 Dose 4Biological
Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1. Receives: Drug: Placebo SC |
| MEDI7836 Dose 1 | Experimental | Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1. Receives: Biological: MEDI7836 Dose 1 |
| MEDI7836 Dose 2 | Experimental | Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1. Receives: Biological: MEDI7836 Dose 2 |
| MEDI7836 Dose 3 | Experimental | Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1. Receives: Biological: MEDI7836 Dose 3 |
| MEDI7836 Dose 4 | Experimental | Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1. Receives: Biological: MEDI7836 Dose 4 |
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) and Treatment-Emergent Serious Adverse Events (TESAEs)
Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.
Measured: From Study Drug Administration to 281 Days Postdose
Number of Participants With Injection Site Reactions
Participants were evaluated for manifestations of injection site reactions.
Measured: From Study Drug Administration to 281 Days Postdose
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Measured: From Study Drug Administration to 281 Days Postdose
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events
Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight. Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system. Criteria for abnormal physical findings was based on investigator's discretion. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.
Measured: From Study Drug Administration to 281 Days Postdose
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: From Study Drug Administration to 281 Days Postdose
Secondary outcomes (8)
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836
Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf).
Measured: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836
Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 to the last quantifiable data point (AUC0-t).
Measured: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Maximum Observed Serum Concentration (Cmax) of MEDI7836
The Cmax is the maximum observed serum concentration of study drug.
Measured: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Apparent Systemic Clearance (CL/F) of MEDI7836
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Terminal Phase Elimination Half Life (T1/2) of MEDI7836
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI7836
The Tmax is defined as actual sampling time to reach maximum observed MEDI7836 concentration.
Measured: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Apparent Terminal-Phase Volume of Distribution (Vz/F) of MEDI7836
The apparent volume of distribution of MEDI7836 after a single dose, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).
Measured: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836
A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Measured: Predose on Day 1 to 281 days Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionApr 2016
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 Healthy AdultsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388347
- Sponsor's protocol ID
- D5450C00001
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2015
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Randomised, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI7836 in Healthy Adults
- ClinicalTrials.gov ID
- NCT02388347
- Acronym / sponsor ID
- D5450C00001
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 12 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects and healthy adult female subjects of non-childbearing potential.
Detailed description
This is a Phase 1a, randomised, blinded (the investigator and subject will be blinded to treatment assignment and sponsor will be unblinded to treatment assignment), placebo-controlled study to evaluate the safety of single-ascending SC doses of MEDI7836 in healthy adult males subjects and healthy adult female subjects of non-childbearing potential. The study will be conducted at a single site in the United Kingdom (UK). Four dosing cohorts of MEDI7836 or placebo are planned for this study for a total of 32 subjects (24 subjects receiving MEDI7836, 8 subjects receiving placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo SCParticipants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1. |
| MEDI7836 Dose 1 | Experimental | Biological: MEDI7836 Dose 1Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1. |
| MEDI7836 Dose 2 | Experimental | Biological: MEDI7836 Dose 2Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1. |
| MEDI7836 Dose 3 | Experimental | Biological: MEDI7836 Dose 3Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1. |
| MEDI7836 Dose 4 | Experimental | Biological: MEDI7836 Dose 4Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Vital signs, ECG, and laboratory parameters within normal range at screening and Day -1
- Negative alcohol and drug screen at screening and Day -1
- Able and willing to comply with the requirements of the protocol
- Females subjects must have been surgically sterilised or be postmenopausal
- Nonsterilised males who are sexually active with a female partner of childbearing potential or a female partner who has been surgically sterilised by bilateral tubal ligation must use a condom with spermicide with their partner from screening until the end of the study follow-up period
Key exclusion criteria (24 listed)
- Concurrent enrolment in another clinical study where the subject is receiving an investigational product
- Individuals who are legally institutionalised
- Receipt of any marketed or investigational biologic agent within 4 months
- Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
- Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half-lives of Day 1,
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 |
|---|---|---|
| Placebo SCParticipants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1. | Drug | Placebo |
| MEDI7836 Dose 1Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1. | Biological | MEDI7836 Dose 1 |
| MEDI7836 Dose 2Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1. | Biological | MEDI7836 Dose 2 |
| MEDI7836 Dose 3Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1. | Biological | MEDI7836 Dose 3 |
| MEDI7836 Dose 4Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1. | Biological | MEDI7836 Dose 4 |
Primary outcome
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From Study Drug Administration to 281 Days Postdose
Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Injection Site Reactions
Time frame: From Study Drug Administration to 281 Days Postdose
Participants were evaluated for manifestations of injection site reactions.
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Time frame: From Study Drug Administration to 281 Days Postdose
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events
Time frame: From Study Drug Administration to 281 Days Postdose
Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight. Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system. Criteria for abnormal physical findings was based on investigator's discretion. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
Time frame: From Study Drug Administration to 281 Days Postdose
AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.
8 secondary outcomes
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836
Time frame: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836
Time frame: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Maximum Observed Serum Concentration (Cmax) of MEDI7836
Time frame: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Apparent Systemic Clearance (CL/F) of MEDI7836
Time frame: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Terminal Phase Elimination Half Life (T1/2) of MEDI7836
Time frame: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI7836
Time frame: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Apparent Terminal-Phase Volume of Distribution (Vz/F) of MEDI7836
Time frame: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836
Time frame: Predose on Day 1 to 281 days Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Annelize Koch, MD principal investigator
Parexel
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 MEDI7836 Dose 1, MEDI7836 Dose 2 and MEDI7836 Dose 3 in people with Healthy Adults, run by MedImmune LLC at 1 site in United Kingdom.
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 5 inclusion and 24 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 16 May 2017. 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 Kingdom. 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 12 Apr 2017). 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) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: From Study Drug Administration to 281 Days Postdose). The study lists 5 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 16 May 2017.