Allergic Asthma, Allergic Rhinitis, Atopic Dermatitis, Healthy Volunteers
Conditions
Keywords
Allergic, Atopic Dermatitis, MEDI4212
Brief summary
Phase 1 study to evaluate the safety of MEDI4212.
Detailed description
A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (\>=) 30 international units per milliliters (IU/mL).
Interventions
OTHERPlacebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
BIOLOGICALOmalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
BIOLOGICALMEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
BIOLOGICALMEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
BIOLOGICALMEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
BIOLOGICALMEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
BIOLOGICALMEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
BIOLOGICALMEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 through 60 years * Written informed consent and any locally required authorization * Body weight 45-150 kilogram (kg) for Cohorts 1-3, 4b, and 5-9. Body weight 45-90 kg for Cohort 4a * Females must have been surgically sterilized or postmenopausal * Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85; Both partners to use contraception * Sterilized males must be at least 1-year post vasectomy or use a highly effective contraceptive method * Healthy Japanese population as determined by a responsible physician * Current diagnosis of allergic rhinitis, allergic asthma, or atopic dermatitis (cohorts 1-6) with a diagnostic immunoglobulin E (IgE) of 30 international units per milliliter (IU/mL) at Screening. Diagnostic IgE levels are further restricted for subjects enrolling into each cohort, with the following levels required at Screening: Cohorts 1 and 2: 30-700 IU/mL; Cohort 3: 30-700 IU/mL (4 subjects), greater than (\>) 700-1,200 IU/mL (4 subjects), and \>1,200 IU/mL (4 subjects); Cohort 4a: 30-500 IU/mL; Cohort 4b: \>700 IU/mL; Cohorts 5 and 6: 30-700 IU/mL (4 subjects per cohort) and \>700 IU/mL (6 subjects per cohort) or Japanese Cohorts 7-9: greater than or equal to (\>=) 30 IU/mL * Nonsmoker for \>=6 months * Obsolete criteria as no longer require Positive in vitro IgE fluorescence enzyme immunoassay (FEIA) response * A forced expiration volume in one second (FEV1) \>= 80 percent (%) predicted in subjects with asthma. Non-asthmatic subjects with FEV1 \>=80% predicted, or with FEV1 less than (\<) 80% predicted but who, in the opinion of the investigator, do not have lung disease * Ability and willingness to complete the follow-up period through Day 85 as required by the protocol.
Exclusion criteria
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * Concurrent enrollment in another clinical study * Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals * Exposure to an anti-IgE monoclonal antibodies (MAb) within 12 months prior to Screening * Positive drug screen at Screening or Day -1. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines * History of regular alcohol abuse within 12 months prior to Screening * History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation * Subjects with abnormal liver function test values (aspartate transaminase \[AST\] and alanine transaminase \[ALT\]) at Screening as defined as follows: a) Liver function test values \>= 1.5 times upper limit of normal (ULN) * Unwillingness or inability to follow the procedures outlined in the protocol * Positive test or history of hepatitis B or positive hepatitis C * Positive test or history of human immunodeficiency virus (HIV) or subject is known to be HIV seropositive * History of cancer, with the exception of basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success * Women who are pregnant, breastfeeding, or lactating * Plans to donate blood during the study period * Hyper-IgE syndrome or bronchopulmonary aspergillosis * Prior history of Immune Complex Disease or type 3 hypersensitivity reactions to MAb administration * Known history of prior infusion reaction to MAb administration * History of untreated parasitic/helminthic infection within 6 months prior to Screening * Uses any of the following medications: a) Oral corticosteroids b) Medium to high dose Immunocorticosteroids (ICS)/ long-acting beta agonists (LABA) c) Immunosuppressives d) Beta blockers * If receiving allergy immunotherapy, must be on stable dose for 3 months. Must not receive allergy immunotherapy within 7 days of investigational product administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 1 to 85 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was 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. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed Serum Concentration | Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85 | Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively. |
| Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | Days 1 (pre-dose), 15, 43, and 85 | Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis. |
| Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only | — |
Countries
United States
Participant flow
Pre-assignment details
A total of 295 participants were screened, out of which 209 were screen failures and 86 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1. | 17 |
| Omalizumab A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1. | 6 |
| MEDI4212 5 mg Subcutaneous A single dose of MEDI4212 5 mg injection subcutaneously on Day 1. | 3 |
| MEDI4212 15 mg Subcutaneous A single dose of MEDI4212 15 mg injection subcutaneously on Day 1. | 3 |
| MEDI4212 60 mg Subcutaneous A single dose of MEDI4212 60 mg injection subcutaneously on Day 1. | 15 |
| MEDI4212 150 mg Subcutaneous A single dose of MEDI4212 150 mg injection subcutaneously on Day 1. | 18 |
| MEDI4212 300 mg Subcutaneous A single dose of MEDI4212 300 mg injection subcutaneously on Day 1. | 14 |
| MEDI4212 300 mg Intravenous A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1. | 8 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Omalizumab | MEDI4212 5 mg Subcutaneous | MEDI4212 15 mg Subcutaneous | MEDI4212 60 mg Subcutaneous | MEDI4212 150 mg Subcutaneous | MEDI4212 300 mg Subcutaneous | MEDI4212 300 mg Intravenous | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 12.6 | 39.3 years STANDARD_DEVIATION 9.2 | 44.7 years STANDARD_DEVIATION 3.2 | 40.3 years STANDARD_DEVIATION 9.6 | 38.7 years STANDARD_DEVIATION 12.5 | 40.3 years STANDARD_DEVIATION 11.1 | 35.9 years STANDARD_DEVIATION 13.1 | 38.0 years STANDARD_DEVIATION 8.6 | 39.0 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 4 Participants | 2 Participants | 0 Participants | 22 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 2 Participants | 1 Participants | 11 Participants | 14 Participants | 12 Participants | 8 Participants | 62 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 17 | 2 / 6 | 2 / 3 | 1 / 3 | 4 / 15 | 9 / 18 | 7 / 14 | 6 / 8 |
| serious Total, serious adverse events | 0 / 17 | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 15 | 0 / 18 | 0 / 14 | 0 / 8 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was 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. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Day 1 to 85
Population: Safety population included all participants who received any amount of investigational product and had safety data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 8 participants |
| Omalizumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| Omalizumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 2 participants |
| MEDI4212 5 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI4212 5 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 2 participants |
| MEDI4212 15 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI4212 15 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 1 participants |
| MEDI4212 60 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 4 participants |
| MEDI4212 60 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI4212 150 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 9 participants |
| MEDI4212 150 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI4212 300 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 7 participants |
| MEDI4212 300 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI4212 300 mg Intravenous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI4212 300 mg Intravenous | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 6 participants |
Secondary
Free Immunoglobulin E (IgE) Serum Concentration
Time frame: Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only
Population: Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 1175.50 ng/mL | Standard Deviation 1550.93 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 1131.87 ng/mL | Standard Deviation 1448.24 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 1155.59 ng/mL | Standard Deviation 1447.09 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 1119.38 ng/mL | Standard Deviation 1417.95 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | NA ng/mL | — |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 913.17 ng/mL | Standard Deviation 1142.25 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 1183.10 ng/mL | Standard Deviation 1494.92 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 1025.19 ng/mL | Standard Deviation 1287.86 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 1185.82 ng/mL | Standard Deviation 1379.2 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 1089.90 ng/mL | Standard Deviation 1306.97 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 1055.20 ng/mL | Standard Deviation 1257.08 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 1084.02 ng/mL | Standard Deviation 1294.17 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 1081.11 ng/mL | Standard Deviation 1338.94 |
| Placebo | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 1160.79 ng/mL | Standard Deviation 1402.74 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 70.95 ng/mL | Standard Deviation 145.36 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 410.78 ng/mL | Standard Deviation 289.39 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 89.32 ng/mL | Standard Deviation 157.95 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 105.46 ng/mL | Standard Deviation 159.88 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | NA ng/mL | — |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 85.00 ng/mL | Standard Deviation 192.16 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 478.99 ng/mL | Standard Deviation 369.31 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 294.89 ng/mL | Standard Deviation 377.39 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 71.89 ng/mL | Standard Deviation 157.68 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 74.94 ng/mL | Standard Deviation 161.38 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 74.02 ng/mL | Standard Deviation 143.04 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 296.73 ng/mL | Standard Deviation 185.09 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 74.85 ng/mL | Standard Deviation 169.36 |
| Omalizumab | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 74.29 ng/mL | Standard Deviation 168.46 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 282.12 ng/mL | Standard Deviation 179.53 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 526.93 ng/mL | Standard Deviation 227.8 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 418.27 ng/mL | Standard Deviation 193.63 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 297.90 ng/mL | Standard Deviation 193.62 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 453.89 ng/mL | Standard Deviation 191.07 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 655.76 ng/mL | Standard Deviation 240.78 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 589.62 ng/mL | Standard Deviation 175.14 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 478.53 ng/mL | Standard Deviation 196.36 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 506.63 ng/mL | Standard Deviation 205.91 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 552.30 ng/mL | Standard Deviation 168.96 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 496.28 ng/mL | Standard Deviation 179.01 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | NA ng/mL | — |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 302.31 ng/mL | Standard Deviation 195.18 |
| MEDI4212 5 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 366.17 ng/mL | Standard Deviation 239.65 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 288.20 ng/mL | Standard Deviation 250.03 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 558.69 ng/mL | Standard Deviation 305.68 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 522.23 ng/mL | Standard Deviation 259.96 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 503.33 ng/mL | Standard Deviation 326.8 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 406.12 ng/mL | Standard Deviation 264.19 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 277.94 ng/mL | Standard Deviation 240.84 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 336.75 ng/mL | Standard Deviation 294.36 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 403.17 ng/mL | Standard Deviation 232.44 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 293.78 ng/mL | Standard Deviation 259.88 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 601.40 ng/mL | Standard Deviation 342.13 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 530.49 ng/mL | Standard Deviation 292.24 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 510.78 ng/mL | Standard Deviation 301.83 |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | NA ng/mL | — |
| MEDI4212 15 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 362.06 ng/mL | Standard Deviation 246.96 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 1704.44 ng/mL | Standard Deviation 3822.59 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 2111.36 ng/mL | Standard Deviation 3730.6 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 2153.91 ng/mL | Standard Deviation 3376.54 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 2201.38 ng/mL | Standard Deviation 3609.05 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 2170.63 ng/mL | Standard Deviation 3899.67 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 2453.85 ng/mL | Standard Deviation 3795.64 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 2754.09 ng/mL | Standard Deviation 4468.96 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | NA ng/mL | — |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 1584.76 ng/mL | Standard Deviation 3999.13 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 1366.58 ng/mL | Standard Deviation 3496.19 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 2712.59 ng/mL | Standard Deviation 4065.37 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 1401.33 ng/mL | Standard Deviation 3429.6 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 2014.95 ng/mL | Standard Deviation 2952.69 |
| MEDI4212 60 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 2102.53 ng/mL | Standard Deviation 4140.14 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 1928.37 ng/mL | Standard Deviation 3371.88 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 366.83 ng/mL | Standard Deviation 1499.49 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | NA ng/mL | — |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 1394.92 ng/mL | Standard Deviation 2394.88 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 362.27 ng/mL | Standard Deviation 1408.5 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 978.17 ng/mL | Standard Deviation 2490.21 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 1910.45 ng/mL | Standard Deviation 3268.58 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 1655.06 ng/mL | Standard Deviation 2866.87 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 1976.98 ng/mL | Standard Deviation 3172.11 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 1676.12 ng/mL | Standard Deviation 3296.43 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 1351.52 ng/mL | Standard Deviation 2803.98 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 1749.34 ng/mL | Standard Deviation 2799.68 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 253.71 ng/mL | Standard Deviation 1045.75 |
| MEDI4212 150 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 248.20 ng/mL | Standard Deviation 1022.97 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 2306.44 ng/mL | Standard Deviation 3511.87 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 2528.85 ng/mL | Standard Deviation 3967.57 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 1775.68 ng/mL | Standard Deviation 2558.08 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 1681.82 ng/mL | Standard Deviation 2161.25 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 1850.27 ng/mL | Standard Deviation 2435.13 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | NA ng/mL | — |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 94.19 ng/mL | Standard Deviation 351.27 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 42.24 ng/mL | Standard Deviation 157.38 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 0.53 ng/mL | Standard Deviation 1.43 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 3.17 ng/mL | Standard Deviation 10.71 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 209.71 ng/mL | Standard Deviation 539.11 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 788.30 ng/mL | Standard Deviation 1783.5 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 1468.72 ng/mL | Standard Deviation 3043.16 |
| MEDI4212 300 mg Subcutaneous | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 1912.71 ng/mL | Standard Deviation 2966.45 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 15 (n=17,6,3,3,15,17,14,8) | 0.00 ng/mL | Standard Deviation 0 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 8 (n=17,6,3,3,15,17,14,8) | 0.00 ng/mL | Standard Deviation 0 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 5 (n=17,6,3,3,15,17,14,8) | 0.00 ng/mL | Standard Deviation 0 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 3 (n=17,6,3,3,15,17,14,8) | 0.00 ng/mL | Standard Deviation 0 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 2 (n=17,6,3,3,15,17,14,8) | 0.00 ng/mL | Standard Deviation 0 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 22 (n=17,6,3,3,15,17,14,8) | 0.32 ng/mL | Standard Deviation 0.6 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 43 (n=16,6,3,3,15,16,13,8) | 1674.54 ng/mL | Standard Deviation 1689.61 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8) | 0.00 ng/mL | Standard Deviation 0 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 1 (Predose) (n=17,6,3,3,15,17,14,8) | 2426.66 ng/mL | Standard Deviation 2460.85 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day -1 (n=17,6,3,3,15,17,14,7) | 2772.55 ng/mL | Standard Deviation 2320.93 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day -28 (n=16,6,3,3,14,15,13,8) | 2641.68 ng/mL | Standard Deviation 2332.13 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 85 (n=15,6,3,3,15,16,12,8) | 2055.68 ng/mL | Standard Deviation 1822.85 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 57 (n=16,6,3,3,15,15,12,8) | 1978.31 ng/mL | Standard Deviation 1906.57 |
| MEDI4212 300 mg Intravenous | Free Immunoglobulin E (IgE) Serum Concentration | Day 29 (n=16,6,3,3,15,17,13,8) | 497.42 ng/mL | Standard Deviation 628.41 |
Secondary
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.
Time frame: Days 1 (pre-dose), 15, 43, and 85
Population: Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | 0 participants |
| Omalizumab | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | 0 participants |
| MEDI4212 5 mg Subcutaneous | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | 0 participants |
| MEDI4212 15 mg Subcutaneous | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | 0 participants |
| MEDI4212 60 mg Subcutaneous | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | 1 participants |
| MEDI4212 150 mg Subcutaneous | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | 0 participants |
| MEDI4212 300 mg Subcutaneous | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | 0 participants |
Secondary
Observed Serum Concentration
Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.
Time frame: Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85
Population: Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Observed Serum Concentration | Day 2 (n=5,1,1,12,17,13,8) | 8941.12 nanogram per milliliter (ng/mL) | Standard Deviation 6361.95 |
| Placebo | Observed Serum Concentration | Day 43 (n=5,2,0,0,5,5,3) | 5195.21 nanogram per milliliter (ng/mL) | Standard Deviation 2263.08 |
| Placebo | Observed Serum Concentration | Day 3 (n=5,1,1,12,17,14,8) | 13912.4 nanogram per milliliter (ng/mL) | Standard Deviation 7546.5 |
| Placebo | Observed Serum Concentration | Day 8 (n=5,0,1,9,16,14,8) | 16467.4 nanogram per milliliter (ng/mL) | Standard Deviation 5374.97 |
| Placebo | Observed Serum Concentration | Day 1 (predose) (n=0,1,0,0,2,1,1) | NA nanogram per milliliter (ng/mL) | — |
| Placebo | Observed Serum Concentration | Day 85 (n=5,2,0,1, 3,1,1) | 829.55 nanogram per milliliter (ng/mL) | Standard Deviation 434.33 |
| Placebo | Observed Serum Concentration | Day 22 (n=5,0,0,6,12,10,8) | 12780.2 nanogram per milliliter (ng/mL) | Standard Deviation 4657.23 |
| Placebo | Observed Serum Concentration | Day 5 (n=5,1,1,11,16,14,8) | 17016.3 nanogram per milliliter (ng/mL) | Standard Deviation 6806.15 |
| Placebo | Observed Serum Concentration | Day 57 (n=5,2,0,0,4,4,3) | 2367.85 nanogram per milliliter (ng/mL) | Standard Deviation 984.7 |
| Placebo | Observed Serum Concentration | Day 15 (n=5,0,0,7,14,13,8) | 15099.6 nanogram per milliliter (ng/mL) | Standard Deviation 5470.44 |
| Placebo | Observed Serum Concentration | Day 29 (n=5,0,0,4,11,8,7) | 9466.26 nanogram per milliliter (ng/mL) | Standard Deviation 4040.07 |
| Placebo | Observed Serum Concentration | Day 1 (postdose) (n=0,0,0,0,0,0,8) | NA nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 57 (n=5,2,0,0,4,4,3) | 122.00 nanogram per milliliter (ng/mL) | Standard Deviation 0.35 |
| Omalizumab | Observed Serum Concentration | Day 5 (n=5,1,1,11,16,14,8) | 116.44 nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 85 (n=5,2,0,1, 3,1,1) | 104.07 nanogram per milliliter (ng/mL) | Standard Deviation 2.48 |
| Omalizumab | Observed Serum Concentration | Day 15 (n=5,0,0,7,14,13,8) | NA nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 2 (n=5,1,1,12,17,13,8) | 100.36 nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 8 (n=5,0,1,9,16,14,8) | NA nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 1 (postdose) (n=0,0,0,0,0,0,8) | NA nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 43 (n=5,2,0,0,5,5,3) | 121.39 nanogram per milliliter (ng/mL) | Standard Deviation 8.11 |
| Omalizumab | Observed Serum Concentration | Day 1 (predose) (n=0,1,0,0,2,1,1) | 96.76 nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 22 (n=5,0,0,6,12,10,8) | NA nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 3 (n=5,1,1,12,17,14,8) | 110.12 nanogram per milliliter (ng/mL) | — |
| Omalizumab | Observed Serum Concentration | Day 29 (n=5,0,0,4,11,8,7) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 8 (n=5,0,1,9,16,14,8) | 190.38 nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 3 (n=5,1,1,12,17,14,8) | 312.73 nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 22 (n=5,0,0,6,12,10,8) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 85 (n=5,2,0,1, 3,1,1) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 57 (n=5,2,0,0,4,4,3) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 43 (n=5,2,0,0,5,5,3) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 1 (predose) (n=0,1,0,0,2,1,1) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 29 (n=5,0,0,4,11,8,7) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 1 (postdose) (n=0,0,0,0,0,0,8) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 15 (n=5,0,0,7,14,13,8) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 2 (n=5,1,1,12,17,13,8) | 292.76 nanogram per milliliter (ng/mL) | — |
| MEDI4212 5 mg Subcutaneous | Observed Serum Concentration | Day 5 (n=5,1,1,11,16,14,8) | 284.28 nanogram per milliliter (ng/mL) | — |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 57 (n=5,2,0,0,4,4,3) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 22 (n=5,0,0,6,12,10,8) | 521.3 nanogram per milliliter (ng/mL) | Standard Deviation 96.73 |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 1 (predose) (n=0,1,0,0,2,1,1) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 1 (postdose) (n=0,0,0,0,0,0,8) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 2 (n=5,1,1,12,17,13,8) | 3146.54 nanogram per milliliter (ng/mL) | Standard Deviation 3820.61 |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 3 (n=5,1,1,12,17,14,8) | 3131.79 nanogram per milliliter (ng/mL) | Standard Deviation 2513.43 |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 5 (n=5,1,1,11,16,14,8) | 3336.31 nanogram per milliliter (ng/mL) | Standard Deviation 2759.69 |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 8 (n=5,0,1,9,16,14,8) | 2368.21 nanogram per milliliter (ng/mL) | Standard Deviation 1364.28 |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 15 (n=5,0,0,7,14,13,8) | 1134.39 nanogram per milliliter (ng/mL) | Standard Deviation 259.41 |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 29 (n=5,0,0,4,11,8,7) | 212.22 nanogram per milliliter (ng/mL) | Standard Deviation 82.96 |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 43 (n=5,2,0,0,5,5,3) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 15 mg Subcutaneous | Observed Serum Concentration | Day 85 (n=5,2,0,1, 3,1,1) | 98.62 nanogram per milliliter (ng/mL) | — |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 5 (n=5,1,1,11,16,14,8) | 7227.93 nanogram per milliliter (ng/mL) | Standard Deviation 3210.9 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 1 (predose) (n=0,1,0,0,2,1,1) | 254.71 nanogram per milliliter (ng/mL) | Standard Deviation 134.58 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 1 (postdose) (n=0,0,0,0,0,0,8) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 43 (n=5,2,0,0,5,5,3) | 1544.4 nanogram per milliliter (ng/mL) | Standard Deviation 2068.43 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 2 (n=5,1,1,12,17,13,8) | 6108.21 nanogram per milliliter (ng/mL) | Standard Deviation 3401.45 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 85 (n=5,2,0,1, 3,1,1) | 202.54 nanogram per milliliter (ng/mL) | Standard Deviation 107.75 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 22 (n=5,0,0,6,12,10,8) | 3401 nanogram per milliliter (ng/mL) | Standard Deviation 2140.78 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 8 (n=5,0,1,9,16,14,8) | 7144.03 nanogram per milliliter (ng/mL) | Standard Deviation 5078.61 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 29 (n=5,0,0,4,11,8,7) | 2176.59 nanogram per milliliter (ng/mL) | Standard Deviation 1390.94 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 15 (n=5,0,0,7,14,13,8) | 4514.83 nanogram per milliliter (ng/mL) | Standard Deviation 2864.46 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 3 (n=5,1,1,12,17,14,8) | 7969.07 nanogram per milliliter (ng/mL) | Standard Deviation 4004.75 |
| MEDI4212 60 mg Subcutaneous | Observed Serum Concentration | Day 57 (n=5,2,0,0,4,4,3) | 290.44 nanogram per milliliter (ng/mL) | Standard Deviation 228.81 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 2 (n=5,1,1,12,17,13,8) | 14971.9 nanogram per milliliter (ng/mL) | Standard Deviation 9608.63 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 8 (n=5,0,1,9,16,14,8) | 12611.1 nanogram per milliliter (ng/mL) | Standard Deviation 8382.56 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 1 (postdose) (n=0,0,0,0,0,0,8) | NA nanogram per milliliter (ng/mL) | — |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 15 (n=5,0,0,7,14,13,8) | 8824.94 nanogram per milliliter (ng/mL) | Standard Deviation 6744.55 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 22 (n=5,0,0,6,12,10,8) | 7454.01 nanogram per milliliter (ng/mL) | Standard Deviation 4682.86 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 1 (predose) (n=0,1,0,0,2,1,1) | 91.69 nanogram per milliliter (ng/mL) | — |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 85 (n=5,2,0,1, 3,1,1) | 84.03 nanogram per milliliter (ng/mL) | — |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 43 (n=5,2,0,0,5,5,3) | 1188.63 nanogram per milliliter (ng/mL) | Standard Deviation 949.33 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 29 (n=5,0,0,4,11,8,7) | 2688.85 nanogram per milliliter (ng/mL) | Standard Deviation 2191.8 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 3 (n=5,1,1,12,17,14,8) | 14771 nanogram per milliliter (ng/mL) | Standard Deviation 8692.16 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 57 (n=5,2,0,0,4,4,3) | 485.18 nanogram per milliliter (ng/mL) | Standard Deviation 249.73 |
| MEDI4212 150 mg Subcutaneous | Observed Serum Concentration | Day 5 (n=5,1,1,11,16,14,8) | 15183.4 nanogram per milliliter (ng/mL) | Standard Deviation 8522.98 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 2 (n=5,1,1,12,17,13,8) | 88457.0 nanogram per milliliter (ng/mL) | Standard Deviation 23398.4 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 5 (n=5,1,1,11,16,14,8) | 34359.5 nanogram per milliliter (ng/mL) | Standard Deviation 6817.4 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 15 (n=5,0,0,7,14,13,8) | 11391.2 nanogram per milliliter (ng/mL) | Standard Deviation 3673.21 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 3 (n=5,1,1,12,17,14,8) | 69776.5 nanogram per milliliter (ng/mL) | Standard Deviation 37738.7 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 57 (n=5,2,0,0,4,4,3) | 150.90 nanogram per milliliter (ng/mL) | Standard Deviation 87.96 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 85 (n=5,2,0,1, 3,1,1) | 176.87 nanogram per milliliter (ng/mL) | — |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 1 (postdose) (n=0,0,0,0,0,0,8) | 110693 nanogram per milliliter (ng/mL) | Standard Deviation 26060.2 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 1 (predose) (n=0,1,0,0,2,1,1) | 158.32 nanogram per milliliter (ng/mL) | — |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 8 (n=5,0,1,9,16,14,8) | 39290.2 nanogram per milliliter (ng/mL) | Standard Deviation 32657.3 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 43 (n=5,2,0,0,5,5,3) | 1669.74 nanogram per milliliter (ng/mL) | Standard Deviation 739.22 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 22 (n=5,0,0,6,12,10,8) | 4644.04 nanogram per milliliter (ng/mL) | Standard Deviation 2571.96 |
| MEDI4212 300 mg Subcutaneous | Observed Serum Concentration | Day 29 (n=5,0,0,4,11,8,7) | 2045.55 nanogram per milliliter (ng/mL) | Standard Deviation 1814.12 |