Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to investigate the safety of administration of this drug by increasing doses to male and female adult subjects with mild asthma.
The primary objective of this study is to investigate the safety of administration of BIW-8405/MEDI-563 in increasing doses to male and female adult subjects with mild asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | MEDI-563 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-563 | Biological | BIW-8405/MEDI-563 administered at one of five dose levels:
Following the -3.0 mg/kg dose level, BIW-8405/MEDI-563 administered at one of two lower dose levels: 0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be the overall incidence of adverse events reported in each dose group. | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory assessments of safety (hematology, biochemistry and urinalysis), assessments of immunogenicity, vital signs, physical examinations, and ECGs. | Day 84 | |
| Safety will also be assessed by measurement of T-cell, B-cell, and NK counts using fluorescence activated cell sorter (FACS) technology. |
Not provided
Inclusion Criteria:
4. Subjects who are considered by the Principal Investigator to be otherwise healthy, as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values that would confound interpretation of the study.
5. Women must be post menopausal, surgically sterile or willing to use birth control for the duration of the study. Birth control may include double barrier methods (e.g., condom with spermicide, hormonal contraceptives (provided they have been used regularly for at least 3 menstrual cycles) or IUD (provided it has remained in situ for at least three menstrual cycles).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nestor Molfino, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish Medical and Research Center | Denver | Colorado | 80206 | United States | ||
| Northeast Medical Research Associates, Inc. |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571386 | benralizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 84 |
| Secondary pharmacological endpoints will include assessments of eosinophil counts in peripheral blood, FENO, and ECP. | Day 84 |
| North Darthmouth |
| Massachusetts |
| 02747 |
| United States |
| Allergy-Asthma-K4 | Madison | Wisconsin | 53792 | United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |