Back to resultsSingle Ascending Dose Study of MEDI1341 in Healthy Volunteers
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI1341
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Healthy Volunteers, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity
Eligibility Criteria
Inclusion Criteria:
- Participants must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening
- Participants must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m^2, inclusive
- Participants must have a 12-lead electrocardiogram recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study
- Participants must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening.
Exclusion Criteria:
- Nicotine use within 6 months before screening
- Considered to be at a high risk of developing a stroke
- Significant medical history of dizziness, blackouts, fainting, or vaso-vagal attacks
- History of any significant ophthalmic disorder, including congenital, genetic or acquired conditions affecting the retina or choroid
- History of severe allergy or history of hypersensitivity to immunizations or immunoglobulins
- History of any significant psychiatric disorder
- History of alcohol abuse
- History of cancer within 5 years of screening
- History of drug abuse
- Any contraindication to Lumbar Puncture
- Any clinically significant abnormality in ECG rhythm, conduction or morphology
- Positive serologic findings at screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies
- Use of prescription or non-prescription drugs
- For female participants, a positive serum or urine pregnancy test result at screening
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Cohort 1: MEDI1341 Dose 1
Cohort 2: MEDI1341 Dose 2
Cohort 3: MEDI1341 Dose 3
Cohort 4: MEDI1341 Dose 4
Cohort 5: MEDI1341 Dose 5
Cohort 6: MEDI1341 Dose 6
Arm Description
Participants will receive a single intravenous (IV) infusion of placebo matched to MEDI1341 and will be followed up for 13 weeks.
Participants will receive a single IV infusion of MEDI1341 Dose 1 and will be followed up for 13 weeks.
Participants will receive a single IV infusion of MEDI1341 Dose 2 and will be followed up for 13 weeks.
Participants will receive a single IV infusion of MEDI1341 Dose 3 and will be followed up for 13 weeks.
Participants will receive a single IV infusion of MEDI1341 Dose 4 and will be followed up for 13 weeks.
Participants will receive a single IV infusion of MEDI1341 Dose 5 and will be followed up for 13 weeks.
Participants will receive a single IV infusion of MEDI1341 Dose 6 and will be followed up for 13 weeks.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are 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 Abnormal Vital Signs, Physical and Neurological Examinations, and Body Weight Measurements Reported as TEAEs
Vital signs assessment included body temperature, respiration rate, pulse rate, and blood pressure. Participants with abnormal vital signs, physical and neurological examinations, and body weight measurements reported as TEAEs are reported.
Change from Baseline in 12-Lead Electrocardiogram (ECG) Data in Paper and Digital Recordings (PR Interval, QRS Duration, QT Interval, QTcF Interval, and RR Interval)
Changes from baseline in 12-Lead ECG data in paper recordings (PR interval, QRS duration, QT interval, and QTcF interval) and digital recordings (PR interval, QRS duration, QT interval, QTcF interval, and RR interval) are reported.
Change from Baseline in Heart Rate by 12-Lead ECG in Paper and Digital Recordings
Change from baseline in heart rate by 12-Lead ECG in paper and digital recordings are reported.
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs
Laboratory assessment included hematology, clinical chemistry, and urinalysis. Participants with abnormal laboratory parameters reported as TEAEs are reported.
Number of Abnormal Findings for Ophthalmic Assessment (Ophthalmic Examination and Slit-lamp Examination) for Placebo and Cohorts 4 to 6 at Follow-up Visit
Number of abnormal findings for ophthalmic assessment (ophthalmic examination and slit-lamp examination) at follow-up visit (Day 57) are reported.
Intraocular Pressure at Screening for Placebo and Cohorts 4 to 6
Intraocular pressure at Screening (Day -49) is reported.
Intraocular Pressure at Day 29 for Placebo and Cohorts 4 to 6
Intraocular pressure at Day 29 is reported.
Intraocular Pressure at Day 92 for Placebo and Cohorts 4 to 6
Intraocular pressure at Day 92 is reported.
Number of Participants With Injection Site Reactions
Participants who had injection site reactions (bleeding, bruising, erythema, swelling, or induration) on Day 1 are reported.
Visual Analogue Scale (VAS) Pain Score for Site Reaction Pain
The VAS (0 to 10 cm) was used to describe reaction site pain. The score 0 means 'no pain at all' and 10 score means 'worst pain imaginable'. The higher the VAS score, the greater the reaction site pain experienced.
Number of Participants With Suicidal Ideation and Suicidal Behavior Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).
Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt (non-fatal), completed suicide.
Number of Participants With Montreal Cognitive Assessment (MoCA) Total Score at Screening (Day -1)
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.
Number of Participants With MoCA Total Score at Day 92
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.
Secondary Outcome Measures
Maximum Observed Serum Concentration (Cmax) of MEDI1341
The Cmax of MEDI1341 is reported.
Time to Maximum Serum Concentration (tmax) of MEDI1341
The tmax of MEDI1341 is reported.
Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of MEDI1341
The AUC0-t of MEDI1341 is reported.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of MEDI1341
The AUC0-∞ of MEDI1341 is reported.
Terminal Half-life (t1/2λz) of MEDI1341
The t1/2λz of MEDI1341 is reported.
Serum Clearance (CL) of MEDI1341
The CL of MEDI1341 is reported.
Volume of Distribution at Steady State (Vss) of MEDI1341
The Vss of MEDI1341 is reported.
Mean Residence Time (MRT) of MEDI1341
The MRT of MEDI1341 is reported.
Percentage Change From Baseline in Plasma Concentrations of Total α-synuclein
Maximum change from baseline through Day 92 and change from baseline at Day 92 in plasma concentrations of total α-synuclein are reported.
Percentage Change From Baseline in Cerebrospinal Fluid Concentrations of Free α-synuclein
Change from baseline in cerebrospinal fluid concentrations of free α-synuclein is reported.
Percentage of Participants With Positive Antidrug Antibodies (ADAs) to MEDI1341 by Titer Levels at Day 92
Percentage of participants with positive ADAs to MEDI1341 by titer levels are reported.
Full Information
NCT ID
NCT03272165
First Posted
June 29, 2017
Last Updated
June 7, 2022
Sponsor
AstraZeneca
Collaborators
Covance, MMS Holdings, Inc, Catalent, Takeda
1. Study Identification
Unique Protocol Identification Number
NCT03272165
Brief Title
Single Ascending Dose Study of MEDI1341 in Healthy Volunteers
Official Title
A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Covance, MMS Holdings, Inc, Catalent, Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study of single ascending intravenous doses of MEDI1341 or placebo in up to 48 healthy volunteers, aged 18 to 65 years. The study will include up to 6 planned cohorts; each cohort will comprise 8 participants.
Each participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled assessments over a period of 13 weeks.
The main aim of the study is to assess the safety and tolerability of single doses of MEDI1341 in healthy volunteers.
Detailed Description
This is a randomized, double-blind, placebo-controlled study of single ascending intravenous doses of MEDI1341 in male and nonfertile female healthy volunteers, aged 18 to 65 years.
The study will include up to 6 planned cohorts; each cohort will comprise 8 participants. Within each cohort, 6 participants will be randomized to receive MEDI1341 and 2 will be randomized to receive placebo. A Safety Review Committee will review data from each cohort before progression to the next higher dose cohort occurs. On Day 1, each randomized participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. Additional study assessments will occur on Days 2, 4, 8, 15, 22, 29, 43, 57, and 92.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Healthy Volunteers, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of two groups within a cohort of 8 participants (N=6 MEDI1341; N=2 placebo)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single intravenous (IV) infusion of placebo matched to MEDI1341 and will be followed up for 13 weeks.
Arm Title
Cohort 1: MEDI1341 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of MEDI1341 Dose 1 and will be followed up for 13 weeks.
Arm Title
Cohort 2: MEDI1341 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of MEDI1341 Dose 2 and will be followed up for 13 weeks.
Arm Title
Cohort 3: MEDI1341 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of MEDI1341 Dose 3 and will be followed up for 13 weeks.
Arm Title
Cohort 4: MEDI1341 Dose 4
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of MEDI1341 Dose 4 and will be followed up for 13 weeks.
Arm Title
Cohort 5: MEDI1341 Dose 5
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of MEDI1341 Dose 5 and will be followed up for 13 weeks.
Arm Title
Cohort 6: MEDI1341 Dose 6
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of MEDI1341 Dose 6 and will be followed up for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
MEDI1341
Other Intervention Name(s)
TAK-341
Intervention Description
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive IV infusion of placebo matched to MEDI1341.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are 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.
Time Frame
Day 1 through 92 days after a single dose of study drug
Title
Number of Participants With Abnormal Vital Signs, Physical and Neurological Examinations, and Body Weight Measurements Reported as TEAEs
Description
Vital signs assessment included body temperature, respiration rate, pulse rate, and blood pressure. Participants with abnormal vital signs, physical and neurological examinations, and body weight measurements reported as TEAEs are reported.
Time Frame
Day 1 through 92 days after a single dose of study drug
Title
Change from Baseline in 12-Lead Electrocardiogram (ECG) Data in Paper and Digital Recordings (PR Interval, QRS Duration, QT Interval, QTcF Interval, and RR Interval)
Description
Changes from baseline in 12-Lead ECG data in paper recordings (PR interval, QRS duration, QT interval, and QTcF interval) and digital recordings (PR interval, QRS duration, QT interval, QTcF interval, and RR interval) are reported.
Time Frame
12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92
Title
Change from Baseline in Heart Rate by 12-Lead ECG in Paper and Digital Recordings
Description
Change from baseline in heart rate by 12-Lead ECG in paper and digital recordings are reported.
Time Frame
12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92
Title
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs
Description
Laboratory assessment included hematology, clinical chemistry, and urinalysis. Participants with abnormal laboratory parameters reported as TEAEs are reported.
Time Frame
Day 1 through 92 days after a single dose of study drug
Title
Number of Abnormal Findings for Ophthalmic Assessment (Ophthalmic Examination and Slit-lamp Examination) for Placebo and Cohorts 4 to 6 at Follow-up Visit
Description
Number of abnormal findings for ophthalmic assessment (ophthalmic examination and slit-lamp examination) at follow-up visit (Day 57) are reported.
Time Frame
Follow-up Visit (Day 57)
Title
Intraocular Pressure at Screening for Placebo and Cohorts 4 to 6
Description
Intraocular pressure at Screening (Day -49) is reported.
Time Frame
Screening (Day -49)
Title
Intraocular Pressure at Day 29 for Placebo and Cohorts 4 to 6
Description
Intraocular pressure at Day 29 is reported.
Time Frame
Day 29
Title
Intraocular Pressure at Day 92 for Placebo and Cohorts 4 to 6
Description
Intraocular pressure at Day 92 is reported.
Time Frame
Day 92
Title
Number of Participants With Injection Site Reactions
Description
Participants who had injection site reactions (bleeding, bruising, erythema, swelling, or induration) on Day 1 are reported.
Time Frame
Day 1
Title
Visual Analogue Scale (VAS) Pain Score for Site Reaction Pain
Description
The VAS (0 to 10 cm) was used to describe reaction site pain. The score 0 means 'no pain at all' and 10 score means 'worst pain imaginable'. The higher the VAS score, the greater the reaction site pain experienced.
Time Frame
Day 1 (within 24 hours after end of infusion)
Title
Number of Participants With Suicidal Ideation and Suicidal Behavior Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).
Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt (non-fatal), completed suicide.
Time Frame
Screening (Day -49) through 92 days after a single dose of study drug
Title
Number of Participants With Montreal Cognitive Assessment (MoCA) Total Score at Screening (Day -1)
Description
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.
Time Frame
Screening (Day -1)
Title
Number of Participants With MoCA Total Score at Day 92
Description
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.
Time Frame
Day 92
Secondary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax) of MEDI1341
Description
The Cmax of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Time to Maximum Serum Concentration (tmax) of MEDI1341
Description
The tmax of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of MEDI1341
Description
The AUC0-t of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of MEDI1341
Description
The AUC0-∞ of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Terminal Half-life (t1/2λz) of MEDI1341
Description
The t1/2λz of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Serum Clearance (CL) of MEDI1341
Description
The CL of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Volume of Distribution at Steady State (Vss) of MEDI1341
Description
The Vss of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Mean Residence Time (MRT) of MEDI1341
Description
The MRT of MEDI1341 is reported.
Time Frame
Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Title
Percentage Change From Baseline in Plasma Concentrations of Total α-synuclein
Description
Maximum change from baseline through Day 92 and change from baseline at Day 92 in plasma concentrations of total α-synuclein are reported.
Time Frame
Baseline (Day 1 predose) through Day 92
Title
Percentage Change From Baseline in Cerebrospinal Fluid Concentrations of Free α-synuclein
Description
Change from baseline in cerebrospinal fluid concentrations of free α-synuclein is reported.
Time Frame
Baseline (Day 1 predose) and Day 29
Title
Percentage of Participants With Positive Antidrug Antibodies (ADAs) to MEDI1341 by Titer Levels at Day 92
Description
Percentage of participants with positive ADAs to MEDI1341 by titer levels are reported.
Time Frame
Day 92
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening
Participants must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m^2, inclusive
Participants must have a 12-lead electrocardiogram recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study
Participants must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening.
Exclusion Criteria:
Nicotine use within 6 months before screening
Considered to be at a high risk of developing a stroke
Significant medical history of dizziness, blackouts, fainting, or vaso-vagal attacks
History of any significant ophthalmic disorder, including congenital, genetic or acquired conditions affecting the retina or choroid
History of severe allergy or history of hypersensitivity to immunizations or immunoglobulins
History of any significant psychiatric disorder
History of alcohol abuse
History of cancer within 5 years of screening
History of drug abuse
Any contraindication to Lumbar Puncture
Any clinically significant abnormality in ECG rhythm, conduction or morphology
Positive serologic findings at screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies
Use of prescription or non-prescription drugs
For female participants, a positive serum or urine pregnancy test result at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanelle Kam, MD, CPI
Organizational Affiliation
Covance Dallas CRU, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John E Blanchard, MD
Organizational Affiliation
Covance Madison CRU, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsor tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Single Ascending Dose Study of MEDI1341 in Healthy Volunteers
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