Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Japanese, phase 2, safety, tolerability, MEDI-545, Autoimmune Disease, Immune System Diseases
Brief summary
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
Interventions
DRUGMEDI-545
Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.
DRUGMEDI-545 600
Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Sponsors
MedImmune LLC
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have previously met ≥4 of the 11 revised ACR criteria * Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening * Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6
Exclusion criteria
* Have received prednisone \>20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1) * Have received the following medications within 28 days before Visit 2 (Day 1): * Systemic cyclophosphamide at any dose * Cyclosporine at any dose * Tacrolimus at any dose * Thalidomide at any dose * Mycophenolate mofetil \>2 g/day * Methotrexate \>15 mg/week * Azathioprine \>2 mg/kg/day * Women who have a positive pregnancy test (serum hCG) at Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Each Category of Adverse Events in Stage I | Stage I (up to 1 year) |
| Number of Participants in Each Category of Adverse Events (AE) in Stage II | Stage II (1 year to 3.5 years after first dose) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | After first dose in Stage I | — |
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | After first dose in Stage I (0 upto 28 days) | — |
| Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | Stage I | — |
| Change From Baseline in 21-gene Signature Fold Change in Stage I | Stage I | 21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene. |
| AUC0-14 of MEDI-545 After First Dose in Stage I | After first dose in Stage I | Summary of area under the concentration-time curve from zero to Day 14. |
Countries
Japan
Participant flow
Recruitment details
This study was conducted at 7 centres in Japan. The first patient was enrolled on 25 November 2009 and the last enrolled patient had completed Stage II on 11 July 2016.
Pre-assignment details
Thirty (30) patients received MEDI-545 either IV or SC treatment (5 patients in each cohort) at Stage I. Twenty-six (26) patients completed Stage I treatment and, out of these 26 patients, 21 patients were registered to continue in Stage II.
Participants by arm
| Arm | Count |
|---|---|
| MEDI-545 1.0 mg/kg IV MEDI-545 1.0 mg/kg IV once every 2 weeks | 5 |
| MEDI-545 3.0 mg/kg IV MEDI-545 3.0 mg/kg IV once every 2 weeks | 5 |
| MEDI-545 10.0 mg/kg IV MEDI-545 10.0 mg/kg IV once every 2 weeks | 5 |
| MEDI-545 100 mg SC MEDI-545 100 mg SC once every 2 weeks | 5 |
| MEDI-545 600 mg IV MEDI-545 600 mg IV once every 4 weeks | 5 |
| MEDI-545 1200 mg IV MEDI-545 1200 mg IV once every 4 weeks | 5 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Stage I | Adverse Event | 1 | 1 | 0 | 0 | 0 | 0 |
| Stage I | Other | 0 | 1 | 0 | 0 | 0 | 1 |
| Stage II | Adverse Event | 0 | 0 | 2 | 2 | 1 | 1 |
| Stage II | Other | 2 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | MEDI-545 1.0 mg/kg IV | MEDI-545 3.0 mg/kg IV | MEDI-545 10.0 mg/kg IV | MEDI-545 100 mg SC | MEDI-545 600 mg IV | MEDI-545 1200 mg IV | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 3 | 43 years STANDARD_DEVIATION 13 | 34 years STANDARD_DEVIATION 9 | 37 years STANDARD_DEVIATION 9 | 46 years STANDARD_DEVIATION 10 | 48 years STANDARD_DEVIATION 13 | 40 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 4 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 5 / 5 | 4 / 5 | 5 / 5 | 5 / 5 | 5 / 5 | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 | 3 / 5 | 3 / 5 | 4 / 5 | 2 / 5 | 5 / 5 |
Outcome results
Primary
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Time frame: Stage II (1 year to 3.5 years after first dose)
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI-545 1.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any serious adverse events (SAE) | 0 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE with outcome=death | 0 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any causally related AE | 2 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE leading to discontinuation of IP | 0 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE | 3 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE of CTC grade at least 3 | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any serious adverse events (SAE) | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE | 1 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE with outcome=death | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE of CTC grade at least 3 | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE leading to discontinuation of IP | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any causally related AE | 1 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE with outcome=death | 0 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any causally related AE | 3 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE leading to discontinuation of IP | 1 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE of CTC grade at least 3 | 1 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE | 4 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any serious adverse events (SAE) | 2 Participants |
| MEDI-545 100mg SC | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE | 4 Participants |
| MEDI-545 100mg SC | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any serious adverse events (SAE) | 4 Participants |
| MEDI-545 100mg SC | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any causally related AE | 4 Participants |
| MEDI-545 100mg SC | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE leading to discontinuation of IP | 3 Participants |
| MEDI-545 100mg SC | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE with outcome=death | 0 Participants |
| MEDI-545 100mg SC | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE of CTC grade at least 3 | 2 Participants |
| MEDI-545 600mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE with outcome=death | 0 Participants |
| MEDI-545 600mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE of CTC grade at least 3 | 3 Participants |
| MEDI-545 600mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE | 5 Participants |
| MEDI-545 600mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any serious adverse events (SAE) | 2 Participants |
| MEDI-545 600mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any causally related AE | 5 Participants |
| MEDI-545 600mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE leading to discontinuation of IP | 1 Participants |
| MEDI-545 1200mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any causally related AE | 4 Participants |
| MEDI-545 1200mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE | 4 Participants |
| MEDI-545 1200mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE of CTC grade at least 3 | 2 Participants |
| MEDI-545 1200mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE with outcome=death | 0 Participants |
| MEDI-545 1200mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any serious adverse events (SAE) | 4 Participants |
| MEDI-545 1200mg IV | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Any AE leading to discontinuation of IP | 1 Participants |
Primary
Number of Participants With Each Category of Adverse Events in Stage I
Time frame: Stage I (up to 1 year)
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI-545 1.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE | 5 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE of CTC grade at least 3 | 0 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE leading to discontinuation of IP | 1 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any causally related AE | 5 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any serious adverse events (SAE) | 0 Participants |
| MEDI-545 1.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE with outcome=death | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE | 4 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE leading to discontinuation of IP | 1 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE of CTC grade at least 3 | 3 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any causally related AE | 3 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE with outcome=death | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any serious adverse events (SAE) | 3 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any serious adverse events (SAE) | 3 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any causally related AE | 5 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE with outcome=death | 0 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE | 5 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE leading to discontinuation of IP | 1 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE of CTC grade at least 3 | 2 Participants |
| MEDI-545 100mg SC | Number of Participants With Each Category of Adverse Events in Stage I | Any AE | 5 Participants |
| MEDI-545 100mg SC | Number of Participants With Each Category of Adverse Events in Stage I | Any AE leading to discontinuation of IP | 0 Participants |
| MEDI-545 100mg SC | Number of Participants With Each Category of Adverse Events in Stage I | Any serious adverse events (SAE) | 0 Participants |
| MEDI-545 100mg SC | Number of Participants With Each Category of Adverse Events in Stage I | Any AE of CTC grade at least 3 | 0 Participants |
| MEDI-545 100mg SC | Number of Participants With Each Category of Adverse Events in Stage I | Any AE with outcome=death | 0 Participants |
| MEDI-545 100mg SC | Number of Participants With Each Category of Adverse Events in Stage I | Any causally related AE | 3 Participants |
| MEDI-545 600mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE leading to discontinuation of IP | 0 Participants |
| MEDI-545 600mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any causally related AE | 4 Participants |
| MEDI-545 600mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE of CTC grade at least 3 | 0 Participants |
| MEDI-545 600mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE with outcome=death | 0 Participants |
| MEDI-545 600mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any serious adverse events (SAE) | 0 Participants |
| MEDI-545 600mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE | 5 Participants |
| MEDI-545 1200mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any causally related AE | 5 Participants |
| MEDI-545 1200mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE | 5 Participants |
| MEDI-545 1200mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE of CTC grade at least 3 | 1 Participants |
| MEDI-545 1200mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE with outcome=death | 0 Participants |
| MEDI-545 1200mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any serious adverse events (SAE) | 3 Participants |
| MEDI-545 1200mg IV | Number of Participants With Each Category of Adverse Events in Stage I | Any AE leading to discontinuation of IP | 0 Participants |
Secondary
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
Time frame: After first dose in Stage I (0 upto 28 days)
Population: Pharmacokinetics (PK) populaton
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MEDI-545 1.0 mg/kg IV | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | 261.98 day*ug/mL | Full Range 16.8 |
| MEID-545 3.0 mg/kg IV | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | 647.93 day*ug/mL | Full Range 7.4 |
| MEDI-545 10.0 mg/kg IV | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | 3040.83 day*ug/mL | Full Range 24.2 |
| MEDI-545 100mg SC | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | 239.16 day*ug/mL | — |
| MEDI-545 600mg IV | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | 2308.44 day*ug/mL | — |
| MEDI-545 1200mg IV | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | 5235.41 day*ug/mL | Full Range 11.6 |
Secondary
AUC0-14 of MEDI-545 After First Dose in Stage I
Summary of area under the concentration-time curve from zero to Day 14.
Time frame: After first dose in Stage I
Population: PK populaton
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI-545 1.0 mg/kg IV | AUC0-14 of MEDI-545 After First Dose in Stage I | 151.28 day*ug/mL | Geometric Coefficient of Variation 19.3 |
| MEID-545 3.0 mg/kg IV | AUC0-14 of MEDI-545 After First Dose in Stage I | 432.26 day*ug/mL | Geometric Coefficient of Variation 11 |
| MEDI-545 10.0 mg/kg IV | AUC0-14 of MEDI-545 After First Dose in Stage I | 1728.01 day*ug/mL | Geometric Coefficient of Variation 16.8 |
| MEDI-545 100mg SC | AUC0-14 of MEDI-545 After First Dose in Stage I | 128.06 day*ug/mL | Geometric Coefficient of Variation 56.1 |
| MEDI-545 600mg IV | AUC0-14 of MEDI-545 After First Dose in Stage I | 1965.44 day*ug/mL | Geometric Coefficient of Variation 41.4 |
| MEDI-545 1200mg IV | AUC0-14 of MEDI-545 After First Dose in Stage I | 4583.55 day*ug/mL | Geometric Coefficient of Variation 15.2 |
Secondary
Change From Baseline in 21-gene Signature Fold Change in Stage I
21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.
Time frame: Stage I
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI-545 1.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 3 | -2.57 fold change | Standard Deviation 2.61 |
| MEDI-545 1.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 29 | 0.03 fold change | Standard Deviation 2.54 |
| MEDI-545 1.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 15 | -1.40 fold change | Standard Deviation 2.56 |
| MEDI-545 1.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 1 8 hours post-dose | -3.70 fold change | Standard Deviation 2.07 |
| MEID-545 3.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 29 | -0.16 fold change | Standard Deviation 8.44 |
| MEID-545 3.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 3 | -4.53 fold change | Standard Deviation 7.02 |
| MEID-545 3.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 1 8 hours post-dose | -5.68 fold change | Standard Deviation 5.92 |
| MEID-545 3.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 15 | -1.11 fold change | Standard Deviation 5.99 |
| MEDI-545 10.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 1 8 hours post-dose | -2.30 fold change | Standard Deviation 0.93 |
| MEDI-545 10.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 15 | -0.41 fold change | Standard Deviation 1.6 |
| MEDI-545 10.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 3 | -2.49 fold change | Standard Deviation 1.06 |
| MEDI-545 10.0 mg/kg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 29 | -0.34 fold change | Standard Deviation 1.38 |
| MEDI-545 100mg SC | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 1 8 hours post-dose | -1.17 fold change | Standard Deviation 0.8 |
| MEDI-545 100mg SC | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 3 | -1.80 fold change | Standard Deviation 0.97 |
| MEDI-545 100mg SC | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 29 | -0.85 fold change | Standard Deviation 0.81 |
| MEDI-545 100mg SC | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 15 | -0.59 fold change | Standard Deviation 1.69 |
| MEDI-545 600mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 15 | -1.61 fold change | Standard Deviation 1.23 |
| MEDI-545 600mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 1 8 hours post-dose | -4.91 fold change | Standard Deviation 2.26 |
| MEDI-545 600mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 3 | -4.81 fold change | Standard Deviation 2.63 |
| MEDI-545 600mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 29 | -1.13 fold change | Standard Deviation 1.4 |
| MEDI-545 1200mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 29 | -1.27 fold change | Standard Deviation 2.46 |
| MEDI-545 1200mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 1 8 hours post-dose | -3.44 fold change | Standard Deviation 1.77 |
| MEDI-545 1200mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 3 | -3.37 fold change | Standard Deviation 1.69 |
| MEDI-545 1200mg IV | Change From Baseline in 21-gene Signature Fold Change in Stage I | Day 15 | -1.84 fold change | Standard Deviation 1.72 |
Secondary
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Time frame: After first dose in Stage I
Population: PK populaton
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI-545 1.0 mg/kg IV | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | 29.04 ug/mL | Geometric Coefficient of Variation 31.3 |
| MEID-545 3.0 mg/kg IV | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | 71.72 ug/mL | Geometric Coefficient of Variation 19.6 |
| MEDI-545 10.0 mg/kg IV | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | 311.17 ug/mL | Geometric Coefficient of Variation 19 |
| MEDI-545 100mg SC | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | 11.70 ug/mL | Geometric Coefficient of Variation 61.1 |
| MEDI-545 600mg IV | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | 244.54 ug/mL | Geometric Coefficient of Variation 47.4 |
| MEDI-545 1200mg IV | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | 607.64 ug/mL | Geometric Coefficient of Variation 16.1 |
Secondary
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
Time frame: Stage I
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MEDI-545 1.0 mg/kg IV | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | 0 Participants |
| MEID-545 3.0 mg/kg IV | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | 1 Participants |
| MEDI-545 10.0 mg/kg IV | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | 0 Participants |
| MEDI-545 100mg SC | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | 0 Participants |
| MEDI-545 600mg IV | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | 0 Participants |
| MEDI-545 1200mg IV | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | 1 Participants |