SAD/MAD Study to Assess Safety, Tolerability, PK & PD of... | NCT02036645 | Trialant
NCT02036645
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Jun 3, 2019Actual
Enrollment
77Actual
Phase
Phase 1
Conditions
Mild-Moderate Alzheimer's Disease
Healthy Elderly
Interventions
MEDI1814 for IV injection
MEDI1814 for Subcutaneous Injection
IV Placebo
Placebo for Subcutaneous Injection
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02036645
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4750C00001
Secondary IDs
Not provided
Brief Title
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Official Title
A Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1814 in Subjects With Mild to Moderate Alzheimer's Disease.
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Feb 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 4, 2014Actual
Primary Completion Date
Sep 15, 2016Actual
Completion Date
Sep 15, 2016Actual
First Submitted Date
Jan 13, 2014
First Submission Date that Met QC Criteria
Jan 13, 2014
First Posted Date
Jan 15, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 15, 2017
Results First Submitted that Met QC Criteria
Feb 21, 2019
Results First Posted Date
Jun 3, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 21, 2019
Last Update Posted Date
Jun 3, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.
Detailed Description
Not provided
Conditions Module
Conditions
Mild-Moderate Alzheimer's Disease
Healthy Elderly
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
77Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI1814 IV
Experimental
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Biological: MEDI1814 for IV injection
IV Placebo
Placebo Comparator
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Biological: MEDI1814 for IV injection
Biological: IV Placebo
MEDI1814 Sub Cutaneous Injection
Experimental
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Biological: MEDI1814 for Subcutaneous Injection
Subcutaneous Placebo
Placebo Comparator
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Biological: Placebo for Subcutaneous Injection
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI1814 for IV injection
Biological
Monoclonal antibody for IV Injection
IV Placebo
MEDI1814 IV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Tolerability as Measured by Participant Withdrawal for an Adverse Event
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
4 months SAD; 7 months MAD
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)
Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)
1 month
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease
Exclusion Criteria History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
55 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Thor Ostenfeld, MD
AstraZeneca
Study Director
David Han, MD
Glendale Parexel Early Phase Clinical Unit
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Glendale
California
91206
United States
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Due to population (mild to moderate Alzheimer's disease) and duration (6 or 9 months) per cohort, rescreening was permitted. SAD had 128 screeings in105 subjects (23 rescreens); MAD had 133 screenings in 88 subjects, (22 rescreens from SAD and 23 rescreens from MAD). Note: 11 of 32 randomized MAD subjects had previously completed a SAD cohort.
Recruitment Details
261 screening visits in 193 individuals were required to randomize 45 subjects into 6 Single Ascending Dose (SAD) cohorts and 32 subjects into 4 Multiple Ascending Dose (MAD) cohorts.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
FG001
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
Periods
Title
Milestones
Reasons Not Completed
SAD Cohorts : Study Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
MEDI1814 for Subcutaneous Injection
Biological
Monoclonal antibody for subcutaneous injection
MEDI1814 Sub Cutaneous Injection
IV Placebo
Biological
Placebo for IV injection
IV Placebo
Placebo for Subcutaneous Injection
Biological
Subcutaneous Placebo Injection
Subcutaneous Placebo
Maximum Plasma Concentration (Cmax) of Medi1814
Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)
1 month
Mean Termination Half Life (t 1/2) of Medi1814
Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)
1 month
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
Day 29 in SAD; Day 85 in MAD
Biomarker: Total Amyloid-beta 1-42 in Plasma
Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Day 29 in SAD; Day 85 in MAD
Medi1814 Concentration in CSF Samples
Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
SAD Day 29; MAD Day 85
Immunogenicity: Anti-drug Antibody Titer
Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50
Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
FG008
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
FG009
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
FG010
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
FG011
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
FG00012 subjectsPooled across cohorts 1-5 (2 per cohort)
FG0013 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG00012 subjects
FG0013 subjects
FG0026 subjects
FG0035 subjects
FG0046 subjects
FG0056 subjects
FG0065 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
MAD Cohorts: Study Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjectsPooled across Cohorts 7 to 9 (2 per cohort)
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0078 subjects
FG0086 subjects
FG0096 subjects
FG0106 subjects
FG0116 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized subjects, Safety Analysis Population
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
BG001
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
BG002
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
BG003
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
BG004
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
BG005
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
BG006
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
BG007
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
BG008
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
BG009
Medi 1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
BG010
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
BG011
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG0013
BG0026
BG0036
BG0046
BG0056
BG0066
BG0078
BG0086
BG0096
BG0106
BG0116
BG01277
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00066.3± 7.22(55 to 79)
BG00174.0± 8.89(67 to 84)
BG00266.8± 1.94(64 to 69)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0008
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Mini Mental State Exam (MMSE)
Mini Mental State Exam (MMSE) - indicator of dementia; range of score of enrolled subjects 16 to 26, Scale range 0 to 30, higher score worse
Mean
Standard Deviation
MMSE score
Title
Denominators
Categories
Title
Measurements
BG00021.8± 3.02
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Tolerability as Measured by Participant Withdrawal for an Adverse Event
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
Safety Population
Posted
Number
Participants
4 months SAD; 7 months MAD
ID
Title
Description
OG000
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
OG001
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG002
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG003
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG004
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
OG005
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
OG006
Medi1814 100 mg SC : SAD
Medi1814 100 mg SC: SAD cohort 6
OG007
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
OG008
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
OG009
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
OG010
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
OG011
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
Units
Counts
Participants
OG00012
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)
Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)
Pharmacokinetic Population (subjects treated with Medi1814)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng x day/mL
1 month
ID
Title
Description
OG000
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG001
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG002
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG003
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
OG004
Medi1814 1800 mg IV: SAD
Secondary
Maximum Plasma Concentration (Cmax) of Medi1814
Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)
Pharmacokinetic population (subjects dosed with Medi1814)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
1 month
ID
Title
Description
OG000
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG001
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG002
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG003
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
OG004
Medi1814 1800 mg IV: SAD
Secondary
Mean Termination Half Life (t 1/2) of Medi1814
Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)
Pharmacokinetic population (subjects dosed with Medi1814)
Posted
Mean
Standard Deviation
days
1 month
ID
Title
Description
OG000
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG001
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG002
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG003
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
OG004
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
Secondary
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
Pharmacodynamic population (with non zero baseline values)
Posted
Mean
Standard Deviation
% change
Day 29 in SAD; Day 85 in MAD
ID
Title
Description
OG000
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
OG001
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG002
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG003
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG004
Medi1814 900 mg IV: SAD
Secondary
Biomarker: Total Amyloid-beta 1-42 in Plasma
Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Pharmacodynamic population (with non zero baseline values)
Posted
Mean
Standard Deviation
% change
Day 29 in SAD; Day 85 in MAD
ID
Title
Description
OG000
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
OG001
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG002
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG003
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG004
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
Secondary
Medi1814 Concentration in CSF Samples
Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
Pharmacokinetic population (subjects dosed with Medi1814)
Posted
Number
Participants
SAD Day 29; MAD Day 85
ID
Title
Description
OG000
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG001
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG002
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG003
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
OG004
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
Secondary
Immunogenicity: Anti-drug Antibody Titer
Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
OG001
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
OG002
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
OG003
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
OG004
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
Time Frame
From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2
Description
Treatment emergent from day of randomization until 4 months after the last dose administration (IV = intravenous dosing; SC = subcutaneous dosing)
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo: SAD
Placebo: pooled SAD pooled cohorts 1, 2, 3, 4, 5 IV & 6 SC (2 subjects each)
0
12
0
12
5
12
EG001
Medi1814 25 mg IV: SAD
Medi1814 25 mg IV: SAD cohort 1
0
3
0
3
1
3
EG002
Medi1814 100 mg IV: SAD
Medi1814 100 mg IV: SAD cohort 2
0
6
0
6
3
6
EG003
Medi1814 300 mg IV: SAD
Medi1814 300 mg IV: SAD cohort 3
0
6
0
6
3
6
EG004
Medi1814 900 mg IV: SAD
Medi1814 900 mg IV: SAD cohort 4
0
6
0
6
6
6
EG005
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
0
6
0
6
1
6
EG006
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
0
6
0
6
4
6
EG007
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
0
8
0
8
3
8
EG008
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
0
6
0
6
4
6
EG009
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
0
6
0
6
3
6
EG010
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
0
6
0
6
2
6
EG011
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
0
6
0
6
2
6
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sinus bradycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
Arnold-Chiari malformation
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Macular degeneration
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Injection site pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Paronychia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eyelid injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural discomfort
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Procedural headache
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
C-reactive protein increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Type 2 diabetes mellitis
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Occipital neuralgia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tension headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hematuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Although 11 subjects were in both a SAD and a MAD cohort, summaries were for those assigned to the cohort regardless of participation in any other cohort
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Michael Pomfret, Project Director, IMED Neuroscience
AstraZeneca Pharmaceuticals
Clinicaltrialstransparency@astrazeneca.net
ID
Term
D007275
Injections, Intravenous
D007279
Injections, Subcutaneous
Ancestor Terms
ID
Term
D061605
Administration, Intravenous
D004333
Drug Administration Routes
D004358
Drug Therapy
D013812
Therapeutics
D007267
Injections
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0078 subjects
FG0086 subjects
FG0096 subjects
FG0106 subjects
FG0116 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
BG00369.0± 6.10(59 to 77)
BG00471.8± 5.15(66 to 78)
BG00564.8± 5.91(56 to 73)
BG00669.3± 4.84(65 to 78)
BG00770.0± 5.90(63 to 80)
BG00871.7± 6.62(65 to 80)
BG00970.8± 6.62(55 to 70)
BG01062.5± 6.16(56 to 79)
BG01169.3± 8.71
BG01268.5± 6.55(55 to 84)
6
BG0035
BG0044
BG0051
BG0063
BG0075
BG0083
BG0092
BG0103
BG0115
BG01244
Male
BG0005
BG0013
BG0020
BG0031
BG0042
BG0055
BG0063
BG0073
BG0083
BG0094
BG0103
BG0111
BG01233
5
BG0034
BG0041
BG0056
BG0061
BG0075
BG0085
BG0095
BG0106
BG0116
BG01252
Not Hispanic or Latino
BG0004
BG0013
BG0021
BG0032
BG0045
BG0050
BG0065
BG0073
BG0081
BG0091
BG0100
BG0110
BG01225
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Asian
BG0001
BG0012
BG0020
BG0031
BG0041
BG0050
BG0061
BG0070
BG0081
BG0090
BG0100
BG0110
BG0127
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Black or African American
BG0001
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0123
White
BG00010
BG0011
BG0026
BG0034
BG0045
BG0056
BG0065
BG0078
BG0085
BG0096
BG0106
BG0115
BG01267
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
22.0
± 2.65
BG00222.3± 3.27
BG00322.5± 3.73
BG00422.2± 2.99
BG00521.0± 2.00
BG00623.2± 2.04
BG00722.1± 2.48
BG00819.8± 2.58
BG00920.2± 1.72
BG01020.0± 2.45
BG01122.5± 2.59
BG01221.6± 3.07
6
OG0046
OG0056
OG0066
OG0078
OG0086
OG0096
OG0106
OG0116
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Medi1814 1800 mg IV: SAD cohort 5
OG005
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
OG006
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
OG007
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
OG008
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
OG009
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
Units
Counts
Participants
OG0003
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
Title
Denominators
Categories
First Dose (day 1-29)
Title
Measurements
OG00080.5± 61.1
OG001455± 19.7
OG0021550± 26.3
OG0034040± 28.0
OG0044420± 30.7
OG005120± 51.9
OG006710± 24.2
OG0071690± 75.3
OG0084490± 24.2
OG009162± 69.2
Third dose (day 57-85)
Title
Measurements
OG000NA± NAsingle dose only
OG001NA± NAsingle dose only
OG002NA± NAsingle dose only
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Regression, Linear
Slope
0.93
2-Sided
95
0.82
1.04
Since an Estimation approach was taken for the statistical analysis, no p-values were calculated
Superiority or Other
OG006
OG007
OG008
Regression, Linear
Slope
1.01
2-Sided
95
0.71
1.30
Since an Estimation approach was taken for the statistical analysis, no p-values were calculated
Superiority or Other
Medi1814 1800 mg IV: SAD cohort 5
OG005
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
OG006
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
OG007
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
OG008
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
OG009
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
Units
Counts
Participants
OG0003
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
Title
Denominators
Categories
First dose (day 1-29)
Title
Measurements
OG00010.2± 42.7
OG00138.7± 30.9
OG002102± 14.7
OG003341± 19.3
OG004424± 36.1
OG0053.59± 51.4
OG00683.9± 22.3
OG007172± 77.2
OG008496± 24.4
OG00910.1± 81.4
Third dose (day 57-85)
Title
Measurements
OG000NA± NASAD - Day 1 dose only
OG001NA± NASAD - Day 1 dose only
OG002NA± NASAD - Day 1 dose only
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Regression, Linear
Slope
0.90
2-Sided
95
0.81
0.98
Since an Estimation approach was taken for the statistical analysis, no p-values were calculated
Superiority or Other
OG006
OG007
OG008
Regression, Linear
Slope
0.96
2-Sided
95
0.65
1.27
Since an Estimation approach was taken for the statistical analysis, no p-values were calculated
Superiority or Other
OG005
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
OG006
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
OG007
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
OG008
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
OG009
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
Units
Counts
Participants
OG0003
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
Title
Denominators
Categories
First dose (day 1-29)
Title
Measurements
OG00017.2± 0.94
OG00117.0± 2.16
OG00217.1± 2.78
OG00319.0± 2.23
OG00418.3± 7.69
OG00519.8± 3.56
OG006NA± NAMAD not assessed after 1st dose
OG007NA± NAMAD not assessed after 1st dose
OG008NA± NAMAD not assessed after 1st dose
OG009NA± NAMAD not assessed after 1st dose
Third dose (day 57-85)
Title
Measurements
OG000NA± NASAD had 1 dose only
OG001NA± NASAD had 1 dose only
OG002NA± NASAD had 1 dose only
OG003
Medi1814 900 mg IV: SAD cohort 4
OG005
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
OG006
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
OG007
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
OG008
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
OG009
Medi1814 900 mg: MAD
Medi1814 900 mg IV: MAD cohort
OG010
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
OG011
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
Units
Counts
Participants
OG00012
OG0013
OG0026
OG0036
OG0046
OG0056
OG0066
OG0078
OG0086
OG0096
OG0106
OG0116
Title
Denominators
Categories
Total amyloid-beta 1-40
Title
Measurements
OG000122.9± 426.51
OG001-15.9± 20.57
OG002-21.0± 19.57
OG0038.72± 31.69
OG0042.0± 29.21
OG00510.2± 98.14
OG006-14.6± 23.69
OG0074.96± 90.19
OG008638.5± 1054.28
OG009-17.9± 34.08
OG010-36.96± 46.82
OG01138.06± 47.51
Total amyloid-beta 1-42
Title
Measurements
OG00025.3± 100.71
OG00152.0± 104.35
OG00241.7± 38.68
OG003
Free amyloid-beta 1-42
Title
Measurements
OG00028.6± 113.70
OG001-33.9± 13.98
OG002-54.3± 39.96
OG003
OG005
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
OG006
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
OG007
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)
OG008
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
OG009
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
OG010
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
OG011
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
Units
Counts
Participants
OG00012
OG0013
OG0026
OG0036
OG0046
OG0056
OG0066
OG0078
OG0086
OG0096
OG0106
OG0116
Title
Denominators
Categories
Title
Measurements
OG00019.6± 34.51
OG00140132.5± 4379.93
OG00241107.0± 43509.89
OG00346667.9± 29628.09
OG00478534.5± 22773.96
OG00544050.9± 15776.40
OG00645404.0± 1808.13
OG007-32.0± 45.65
OG00830272.4± 14834.80
OG00984652.8± 44649.16
OG01043415.3± 13760.07
OG01197140.1± 34151.47
OG005
Medi1814 100 mg SC: SAD
Medi1814 100 mg SC: CAD cohort 6
OG006
Medi1814 300 mg IV: MAD
Medi1814 300 mg IV: MAD cohort 7
OG007
Medi1814 900 mg IV: MAD
Medi1814 900 mg IV: MAD cohort 8
OG008
Medi1814 1800 mg IV: MAD
Medi1814 1800 mg IV: MAD cohort 9
OG009
Medi1814 200 mg SC: MAD
Medi1814 200 mg SC: MAD cohort 10
Units
Counts
Participants
OG0003
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
Title
Denominators
Categories
First dose (day 1-29)
Title
Measurements
OG0000± 0.94
OG0010± 2.16
OG0021± 2.78
OG0032± 2.23
OG0044± 7.69
OG0050± 3.56
OG006NA± NAMAD not assessed after first dose
OG007NA± NAMAD not assessed after first dose
OG008NA± NAMAD not assessed after first dose
OG009NA± NAMAD not assessed after first dose
Third dose (day 57-85)
Title
Measurements
OG000NA± NASAD only 1 dose
OG001NA± NASAD only 1 dose
OG002NA± NASAD only 1 dose
OG003
OG005
Medi1814 1800 mg IV: SAD
Medi1814 1800 mg IV: SAD cohort 5
OG006
Medi1814 100 mg SC : SAD
Medi1814 100 mg SC: SAD cohort 6
OG007
Placebo: MAD
Placebo: MAD pooled cohorts 7, 8, 9 IV & 10 SC (2 subjects each)